Philips recall: Achieva 1.5T and 11 more products

Philips North America Llc is recalling Achieva 1.5T and 11 more products – 387; 210; 15; 91; 2038; 922; 1447; 596; 82; 611; 37; 965. The U.S. Food and Drug Administration published the recall on September 30, 2026; it began on August 21, 2026. Distributed nationwide.

Serious Class II means the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.

1. Achieva 1.5T, Achieva 1.5T Conversion and Achieva 1.5T Initial system; Model Numbers (REF): 1. 781196 (Achieva 1.5T), 2. 781343 (Achieva 1.5T), 3. 781283 (Achieva 1.5T Conversion), 4. 781346 (Achieva 1.5 Conversion), 5. 781178 (Achieva 1.5T Initial System);

   FDA recall number

   Z-3232-2026

   Codes, lots and dates

   1. Model Numbers (REF): 781196 (Achieva 1.5T); UDI-DI: N/A; Serial Numbers: 22135, 21807, 22149, 22162, 22186, 22264, 21329, 21787, 21989, 22022, 22150, 22180, 22270, 21674, 22080, 21190, 21254, 21315, 21530, 21592, 21903, 21913, 21914, 22072, 22076, 22161, 22176, 22217, 22278, 21796, 21996, 21306, 21499, 21525, 21556, 21626, 21897, 21985, 22213, 22056, 21342, 21571, 21594, 21810, 21924, 22335, 21235, 21492, 22198, 21243, 21449, 22029, 22069, 21731, 22095, 22185, 22239, 22108, 22079, 21984, 21073, 21211, 21269, 21487, 21488, 21550, 21598, 21624, 21808, 22071, 22223, 21911, 21225, 21954, 21215, 21397, 21431, 21689, 21986, 22021, 22243, 21427, 22117, 22326, 21076, 21104, 21183, 21264, 21272, 21284, 21321, 21334, 21351, 21405, 21455, 21479, 21494, 21508, 21572, 21574, 21589, 21666, 21776, 21805, 21868, 21879, 21935, 21957, 21968, 21993, 22001, 22004, 22066, 22130, 22136, 22155, 22207, 22258; 2. Model Numbers (REF): 781343 (Achieva 1.5T); UDI-DI: 884838055292; Serial Numbers: 72020, 72104, 72137, 72138, 72146, 72157, 72160, 72170, 72171, 72179, 72183, 72185, 72200, 72223, 72233, 72238, 72251, 72269, 72013, 72111, 72113, 72231, 72235, 72270, 72271, 72273, 72286, 72079, 72083, 72109, 72120, 72122, 72123, 72124, 72126, 72139, 72141, 72142, 72147, 72150, 72247, 72007, 72156, 72101, 72116, 72117, 72180, 72197, 72267, 72189, 72008, 72080, 72036, 72052, 72057, 72103, 72134, 72143, 72144, 72145, 72151, 72186, 72199, 72217, 72224, 72227, 72228, 72236, 72253, 72254, 72255, 72256, 72257, 72258, 72259, 72260, 72264, 72278, 72279, 72296, 72297, 72298, 72299, 72304, 72029, 72129, 72153, 72175, 72194, 72207, 72281, 72290, 72301, 72302, 72310, 72311, 72316, 72320, 72321, 72326, 72329, 72075, 72076, 72261, 72022, 72047, 72100, 72154, 72159, 72240, 72285, 72287, 72317, 72324, 72015, 72016, 72023, 72071, 72074, 72205, 72038, 72322, 72053, 72063, 72077, 72118, 72121, 72177, 72188, 72192, 72202, 72203, 72265, 72274, 72288, 72289, 72308, 72313, 72048, 72001, 72058, 72230, 72234, 72102, 72201, 72003, 72040, 72114, 72010, 72049, 72055, 72136, 72148, 72266, 72319, 72222, 72034, 72198, 72220, 72226, 72119, 72168, 72303, 72309, 72312, 72318, 72025, 72066, 72193, 72325, 72327, 72331, 72174, 72082, 72249; 3. Model Numbers (REF): 781283 (Achieva 1.5T Conversion); UDI-DI: N/A; Serial Numbers: 39056, 8989, 10126, 39098, 39108, 39004, 39010, 39028, 39032, 39086, 39094, 39095, 39058, 39091, 39105, 39053, 39073, 39067, 39016, 39025; 4. Model Numbers (REF): 781346 (Achieva 1.5 Conversion); UDI-DI: N/A; Serial Numbers: 18052, 8361, 8415, 10015, 75008, 5243, 8727, 10172, 10189, 10545, 18737, 75002, 75003, 75004, 75015, 8059, 8757, 8767, 8842, 8883, 8886, 8897, 8946, 8974, 8981, 8990, 10060, 18001, 18710, 75009, 75092, 75095, 75099, 75100, 8069, 8312, 8520, 10006, 10048, 18588, 75000, 75001, 75005, 75031, 75049, 75087, 8371, 8289, 8367, 8740, 10539, 75011, 8351, 8782, 8756, 75010, 75007, 8124, 8020; 5. Model Numbers (REF): 781178 (Achieva 1.5T Initial System); UDI-DI: N/A; Serial Numbers: 20095, 20056, 20230, 20258, 20085, 20094, 20113, 20050, 20072, 20088, 20096, 20252, 20281, 20297, 20307;

   Quantity

   387

   Classification

   Class II

2. Achieva 3.0T; Model Numbers (REF): 1. 781177, 2. 781277, 3. 781278, 4. 781344, 5. 781345;

   FDA recall number

   Z-3233-2026

   Codes, lots and dates

   1. Model Numbers (REF): 781177; UDI-DI: N/A; Serial Numbers: 17144, 17376, 17448, 24049, 17099, 24138, 24060, 17607, 17079, 17146, 17189, 17379, 17469, 17270, 17432, 17279, 17233, 17295, 17446, 17362, 24068, 24096, 17139, 24037, 24099, 17535, 24079, 17030, 17043, 17056, 17114, 17149, 17161, 17167, 17170, 17179, 17216, 17217, 17235, 17251, 17316, 17319, 17365, 17453, 17494, 17523, 17558, 17561, 24038, 24070, 24089; 2. Model Numbers (REF): 781277; UDI-DI: N/A; Serial Numbers: 34289, 34213, 34276, 34113, 34123, 34239, 34264, 34274, 34285, 34095, 34138, 34305, 34118, 34106, 34159, 34241, 34263, 34139, 34002, 34029, 34034, 34071, 34201; 3. Model Numbers (REF): 781278; UDI-DI: N/A; Serial Numbers: 38326, 38346, 38043, 38098, 38108, 38152, 38157, 38194, 38210, 38212, 38215, 38231, 38233, 38236, 38238, 38240, 38267, 38269, 38270, 38271, 38284, 38312, 38321, 38328, 38332, 38338, 38339, 38340, 38344, 38349, 38367, 38370, 38401, 38402, 38405, 38407, 38408, 38412, 38415, 38420, 38421, 38423, 38425, 38426, 38427, 38430, 38431, 38432, 38433, 38437, 38439, 38441, 38442, 38443, 38445, 38447, 38448, 38450, 38453, 38454, 38456, 38457, 38458, 38288, 38079, 38139, 38228, 38145, 38034, 38251, 38278, 38207, 38061, 38086, 38095, 38115, 38133, 38017, 38064, 38112, 38143, 38160, 38183, 38229, 38256, 38296, 38297, 38315, 38331, 38272, 38322, 38323, 38337, 38345, 38077, 38200, 38268, 38090, 38188, 38093, 38012, 38099, 38003, 38057, 38072, 38085, 38016, 38033, 38091, 38103, 38173, 38341, 38232; 4. Model Numbers (REF): 781344; UDI-DI: N/A; Serial Numbers: 73005, 73008, 73009, 73006, 73010; 5. Model Numbers (REF): 781345; UDI-DI: N/A; Serial Numbers: 74027, 74035, 74039, 74047, 74052, 74001, 74010, 74026, 74046, 74005, 74007, 74021, 74030, 74040, 74044, 74048, 74032, 74037;

   Quantity

   210

   Classification

   Class II

3. Achieva XR; Model Numbers (REF): 1. 781153, 2. 781253;

   FDA recall number

   Z-3234-2026

   Codes, lots and dates

   1. Model Numbers (REF): 781153; UDI-DI: N/A; Serial Numbers: 23035, 23003, 23021, 23028; 2. Model Numbers (REF): 781253; UDI-DI: N/A; Serial Numbers: 35028, 35068, 35083, 35074, 35049, 35004, 35006, 35011, 35015, 35050, 35076;

   Quantity

   15

   Classification

   Class II

4. Evolution upgrade 1.5T and Evolution upgrade 3.0T; Model Numbers (REF): 1. 782116 (1.5T), 2. 782148 (1.5T), 3. 782117 (3.0T), 4. 782143 (3.0T);

   FDA recall number

   Z-3235-2026

   Codes, lots and dates

   1. Model Numbers (REF): 782116 (1.5T); UDI-DI: 884838099722; Serial Numbers: 41130, 70284, 41491, 41196, 41520, 70068, 41024, 41025, 41051, 41139, 41144, 41286, 41327, 41349, 41424, 41432, 41433, 70099, 70202, 81073, 41344, 41229, 41457, 41497, 41413, 41080, 41527, 70205, 70589, 81021, 41179, 41189, 70949; 2. Model Numbers (REF): 782148 (1.5T); UDI-DI: 884838108714; Serial Numbers: 41523, 70630, 70966, 84102, 84473, 84825, 41031, 41043, 41085, 41284, 41392, 41553, 70596, 81006, 70644, 41488, 41534, 70454, 41167, 41375, 41446, 70652, 41011, 70590, 70195, 84628; 3. Model Numbers (REF): 782117 (3.0T); UDI-DI: 884838099739; Serial Numbers: 42246, 85713, 42029, 71774, 85668, 85680, 85685, 85694, 42023, 42024, 42078, 42217, 42402, 71348, 71044, 85698, 85146, 42003, 85663, 85677; 4. Model Numbers (REF): 782143 (3.0T); UDI-DI: N/A; Serial Numbers: 71815, 42440, 71389, 85688, 85690, 85649, 42193, 42366, 85683, 85697, 85701, 85708;

   Quantity

   91

   Classification

   Class II

5. Ingenia 1.5T, Ingenia 1.5T CX and Ingenia 1.5T S; Model Numbers (REF): 1. 781315(1.5T), 2. 781341(1.5T), 3. 781396(1.5T), 4. 782101(1.5T), 5. 782115(1.5T), 6. 782140(1.5T), 7. 781261(1.5T CX), 8. 781262(1.5T CX), 9. 781347(1.5T S);

   FDA recall number

   Z-3236-2026

   Codes, lots and dates

   1. Model Numbers (REF): 781315(1.5T); UDI-DI: 884838099715; Serial Numbers: 61019, 61140, 61080, 61067, 61091, 61114, 61028, 61039, 61040, 61041, 61000, 61002, 61003, 61006, 61009, 61017, 61032, 61058, 61065, 61066, 61074, 61075, 61097, 61106, 61124, 61001, 61004, 61011, 61023, 61025, 61026, 61034, 61035, 61042, 61046, 61115, 61078, 61015, 61119, 61005, 61020, 61043, 61085, 61088, 61036, 61052, 61057, 61061, 61068, 61069, 61070, 61072, 61095, 61117, 61125, 61126, 61129, 61130, 61027, 61108, 61109, 61131, 61144, 61107, 61138, 61142, 61102, 61103, 61014, 61018, 61016, 61038, 61073, 61079, 61082, 61084, 61092, 61093, 61096, 61022, 61044, 61049, 61050, 61053; 2. Model Numbers (REF): 781341(1.5T); UDI-DI: 884838055322; Serial Numbers: 87260, 70040, 70229, 70607, 70763, 84030, 84108, 84234, 84257, 84596, 87005, 87146, 70603, 70604, 70605, 70725, 70767, 70768, 70812, 70232, 70367, 70374, 70375, 70764, 70780, 84566, 84621, 84629, 84667, 87214, 87215, 70193, 70485, 70488, 70831, 70832, 70833, 70071, 70311, 84098, 84343, 84765, 70110, 70111, 70161, 70177, 70204, 70244, 70269, 70446, 70448, 70459, 70470, 70612, 70662, 70663, 70664, 70665, 70666, 70667, 70668, 70678, 70691, 70755, 70845, 70864, 70866, 70867, 70868, 70942, 70943, 70969, 84178, 84179, 84180, 84302, 84303, 84330, 84381, 84384, 84385, 84387, 84844, 84976, 87028, 87098, 87124, 87125, 87126, 87135, 87177, 87180, 87206, 87207, 87221, 87222, 87271, 87290, 87297, 84249, 84891, 70286, 70641, 70655, 70712, 70730, 70851, 84649, 84092, 84311, 84730, 84744, 84766, 84890, 84982, 84986, 87151, 87171, 87191, 70974, 70981, 70987, 70997, 84010, 84066, 84082, 84150, 84153, 84197, 84204, 84230, 84242, 84256, 84262, 84287, 84290, 84291, 84310, 84318, 84320, 84321, 84327, 84383, 84389, 84397, 84399, 84411, 84422, 84427, 84496, 84503, 84515, 84531, 84582, 84585, 84588, 84608, 84645, 84673, 84692, 84770, 84810, 84812, 84813, 84822, 84830, 84831, 84833, 84855, 84857, 84859, 84861, 84863, 84872, 84922, 84928, 84943, 84946, 84984, 84990, 84997, 87009, 87029, 87045, 87048, 87054, 87056, 87084, 87109, 87110, 87113, 87114, 87123, 87142, 87174, 87181, 87192, 87201, 87202, 87224, 87227, 87233, 87240, 87241, 87248, 87254, 87257, 87268, 87272, 87274, 87283, 87284, 87291, 87294, 87299, 87300, 87302, 87303, 87305, 87307, 87311, 87312, 87314, 87315, 87317, 87318, 87320, 87326, 87138, 84551, 70654, 84792, 87112, 84195, 70369, 70965, 70333, 70778, 84407, 84408, 84547, 84687, 70250, 70258, 84488, 87141, 84664, 70601, 87008, 70296, 70597, 70818, 70885, 70976, 70991, 84051, 84164, 84165, 84166, 84167, 84175, 84176, 84322, 84323, 84342, 84425, 84471, 84593, 84742, 87139, 87266, 84704, 84705, 70796, 84412, 70598, 84271, 84341, 84474, 84671, 84681, 84807, 84850, 84867, 84910, 84920, 84921, 87076, 70021, 70029, 70129, 70199, 70270, 70277, 70294, 70302, 70381, 70427, 70463, 70464, 70583, 70611, 70617, 70626, 70651, 70673, 70680, 70684, 70692, 70784, 70785, 70799, 70854, 70855, 70870, 70881, 70921, 70929, 70986, 70992, 70993, 84016, 84104, 84116, 84122, 84131, 84155, 84187, 84207, 84228, 84259, 84395, 84404, 84423, 84438, 84453, 84454, 84487, 84544, 84564, 84565, 84574, 84624, 84632, 84654, 84718, 84829, 84914, 84996, 87081, 87100, 87249, 87262, 84801, 84900, 84901, 70599, 70347, 70648, 70797, 84047, 84789, 87111, 70804, 84806, 70119, 70280, 70339, 70361, 70695, 70717, 70773, 70788, 70865, 70897, 70931, 70932, 70933, 70962, 70967, 84070, 84095, 84096, 84241, 84245, 84292, 84298, 84372, 84374, 84375, 84401, 84421, 84455, 84456, 84458, 84477, 84518, 84519, 84520, 84521, 84522, 84523, 84524, 84598, 84657, 84676, 84677, 84678, 84679, 84680, 84693, 84757, 84832, 84948, 84955, 87000, 87050, 87219, 87285, 87319, 84218, 70196, 70334, 70335, 70384, 70423, 70703, 70918, 70919, 84209, 84211, 84216, 84261, 84331, 84494, 84719, 84720, 87276, 87277, 87278, 87279, 87282, 87129, 87131, 87155, 87213, 87281, 70072, 70613, 70934, 70146, 70201, 70281, 70287, 70658, 84015, 87058, 70027, 70144, 70228, 70300, 70585, 70591, 70592, 70702, 70726, 70746, 70765, 70786, 70795, 70798, 70809, 70817, 70823, 70834, 70935, 70946, 70961, 84007, 84081, 84083, 84091, 84124, 84125, 84127, 84135, 84144, 84177, 84220, 84269, 84382, 84413, 84420, 84431, 84491, 84502, 84513, 84530, 84536, 84594, 84604, 84606, 84851, 84864, 84871, 84937, 84952, 84956, 84988, 84994, 84995, 87115, 87165, 87236, 70011, 70013, 70037, 70038, 70039, 70053, 70055, 70056, 70084, 70192, 70203, 70263, 70273, 70299, 70329, 70343, 70379, 70402, 70436, 70460, 70595, 70649, 70682, 70720, 70732, 70734, 70735, 70736, 70738, 70747, 70772, 70774, 70789, 70792, 70800, 70805, 70813, 70825, 70827, 70836, 70848, 70850, 70859, 70861, 70889, 70909, 70920, 70926, 70970, 84008, 84027, 84028, 84032, 84034, 84035, 84052, 84060, 84061, 84062, 84065, 84079, 84099, 84114, 84118, 84149, 84172, 84191, 84194, 84226, 84229, 84233, 84247, 84255, 84266, 84309, 84335, 84357, 84376, 84394, 84396, 84444, 84480, 84492, 84495, 84534, 84535, 84550, 84556, 84583, 84603, 84641, 84647, 84650, 84659, 84666, 84670, 84697, 84706, 84713, 84721, 84722, 84724, 84745, 84747, 84748, 84751, 84775, 84793, 84805, 84818, 84819, 84820, 84839, 84858, 84873, 84879, 84895, 84904, 84918, 84930, 84977, 87001, 87023, 87026, 87038, 87117, 87136, 87175, 87176, 87187, 87190, 87204, 87234, 87235, 87238, 87239, 87242, 87289, 87293, 84231, 84086, 84275, 84826, 84940, 87210, 70238, 70261, 70891, 84661, 84847, 87079, 84349, 84350, 84351, 84352, 84353, 84354, 84355, 84025, 84347, 70128, 70198, 70593, 84490, 87212, 84772, 84854, 87036, 87037, 84716, 70318, 87296, 70930, 84068, 70264, 70708, 70908, 84013, 84089, 84199, 84221, 84250, 84368, 84430, 84571, 84572, 84600, 84602, 84700, 84834, 84862, 84885, 84983, 84443, 84852, 70777, 70262, 70637, 70679, 70714, 70910, 70998, 84138, 84140, 84217, 84278, 84398, 70075, 70947, 70960, 84115, 84148, 84587, 84752, 87143, 87144, 70131, 70481, 70628, 70722, 84145, 70136, 84045, 84046, 70048, 70065, 70066, 70255, 70711, 87078, 87269, 70282, 84611, 70828, 84057, 84288, 84424, 70022, 70371, 70437, 70775, 70830, 84029, 84363, 84573, 84605, 84689, 87003, 87102, 70236, 70271, 84067, 84709, 84113, 84888, 70416, 70945, 84129, 87116, 70140, 70337, 70350, 70351, 70357, 70368, 70401, 70428, 70449, 70486, 70487, 70489, 70490, 70624, 70683, 70686, 70744, 70745, 70811, 70840, 70847, 70900, 70954, 70985, 84021, 84039, 84069, 84097, 84142, 84171, 84198, 84244, 84279, 84305, 84361, 84362, 84428, 84599, 84626, 84637, 84653, 84662, 84717, 84726, 84729, 84738, 84758, 84759, 84796, 84865, 84931, 84934, 84975, 84989, 87024, 87031, 87069, 87071, 87147, 87152, 87153, 87154, 87161, 87172, 87185, 87188, 87208, 87211, 87237, 87244, 87265, 87280, 70194, 70242, 70314, 70697, 70776, 70806, 70871, 70888, 84087, 84258, 84472, 84613, 84746, 84798, 84802, 87035, 87044, 87049, 87082, 87090, 87093, 70759, 70685, 70733, 70915, 84933, 70429, 70982, 84557, 70025, 70434, 70689, 70802, 84402, 84577, 84675, 70123, 70226, 70235, 70251, 70295, 70364, 70383, 70435, 70629, 70656, 70844, 70890, 70927, 70973, 84004, 84224, 84312, 84313, 84332, 84371, 84437, 84546, 84554, 84576, 84584, 84592, 84663, 84740, 84773, 84774, 84896, 87004, 87034, 87039, 87119, 87134, 87253, 70026, 70952, 84470, 70074, 70114, 70306, 70623, 70754, 70869, 84084, 84268, 84315, 87027, 70058, 70426, 70468, 70791, 70849, 84036, 84037, 84616, 84633, 84651, 84827, 84828, 84868, 87226, 70230, 84206, 84214, 84308, 84416, 84479, 84482, 84558, 84620, 84656, 84808, 84809, 84848, 70356, 70358, 70359, 70677, 70057, 70080, 70087, 70097, 70157, 70610, 70693, 70810, 84002, 84003, 84074, 84237, 84239, 84338, 84339, 84367, 84483, 84767, 84849, 84913, 84915, 84960, 84969, 87022, 87086, 87087, 87094, 87095, 87158, 87163, 87259, 70239, 87209, 70085, 70160, 70246, 70348, 70349, 70407, 70723, 70873, 70917, 87101, 70148, 70191, 70297, 70301, 70316, 70440, 70453, 70465, 70482, 70587, 70608, 70770, 70843, 70872, 70887, 70899, 70906, 70914, 70994, 84005, 84038, 84137, 84154, 84208, 84210, 84252, 84293, 84297, 84306, 84325, 84334, 84346, 84377, 84406, 84445, 84690, 84838, 84869, 87083, 87194, 70044, 70049, 70052, 70063, 70076, 70095, 70156, 70190, 70200, 70233, 70292, 70298, 70308, 70312, 70321, 70328, 70403, 70451, 70455, 70606, 70614, 70621, 70627, 70636, 70646, 70650, 70675, 70676, 70694, 70698, 70699, 70700, 70706, 70709, 70719, 70727, 70729, 70752, 70762, 70771, 70779, 70783, 70808, 70819, 70835, 70857, 70863, 70874, 70892, 70893, 70894, 70898, 70903, 70911, 70939, 70951, 70972, 84012, 84026, 84043, 84063, 84075, 84077, 84088, 84134, 84147, 84157, 84168, 84170, 84173, 84174, 84189, 84196, 84200, 84225, 84264, 84274, 84280, 84282, 84283, 84286, 84314, 84316, 84340, 84344, 84400, 84410, 84432, 84434, 84439, 84440, 84441, 84446, 84460, 84462, 84469, 84475, 84481, 84484, 84485, 84498, 84499, 84505, 84506, 84508, 84509, 84514, 84526, 84537, 84538, 84552, 84614, 84627, 84644, 84646, 84674, 84734, 84741, 84791, 84799, 84811, 84816, 84821, 84823, 84824, 84836, 84866, 84889, 84894, 84911, 84929, 84935, 84942, 84970, 84973, 84993, 87017, 87019, 87043, 87055, 87057, 87097, 87103, 87120, 87132, 87133, 87218, 87231, 87245, 70179, 70883, 84251, 84284, 84776, 84777, 84778, 84779, 84780, 84781, 84782, 84783, 70657, 70154, 70710, 87232, 87247; 3. Model Numbers (REF): 781396(1.5T); UDI-DI: 884838009820; Serial Numbers: 41175, 41176, 41007, 41039, 41127, 41157, 41256, 41350, 41132, 41186, 41230, 41268, 41359, 41441, 41521, 41584, 41204, 41449, 41151, 41518, 41524, 41610, 41615, 41617, 41618, 41619, 41509, 41591, 41045, 41108, 41180, 41314, 41366, 41397, 41486, 41519, 41436, 41070, 41351, 41010, 41016, 41029, 41052, 41071, 41084, 41112, 41125, 41131, 41141, 41142, 41160, 41178, 41192, 41210, 41211, 41228, 41240, 41283, 41335, 41338, 41368, 41380, 41381, 41388, 41389, 41395, 41417, 41442, 41454, 41473, 41538, 41540, 41561, 41009, 41050, 41113, 41272, 41480, 41087, 41093, 41096, 41129, 41163, 41184, 41193, 41213, 41217, 41220, 41246, 41257, 41267, 41352, 41365, 41399, 41494, 41502, 41522, 41545, 41049, 41060, 41068, 41074, 41106, 41117, 41124, 41126, 41128, 41133, 41136, 41153, 41243, 41280, 41292, 41298, 41299, 41357, 41408, 41435, 41437, 41452, 41493, 41496, 41507, 41513, 41543, 41544, 41549, 41558, 41559, 41565, 41570, 41571, 41115, 41405, 41560, 41020, 41169, 41188, 41293, 41458, 41466, 41467, 41474, 41013, 41100, 41140, 41190, 41214, 41249, 41301, 41450, 41461, 41304, 41075, 41562, 41164, 41219, 41296, 41331, 41394, 41111, 41594, 41407, 41476, 41477, 41479, 41003, 41162, 41172, 41185, 41191, 41254, 41255, 41498, 41515, 41138, 41259, 41440, 41531, 41329, 41478, 41146, 41318, 41355, 41371, 41376, 41423, 41453, 41548, 41000, 41006, 41015, 41021, 41022, 41028, 41035, 41037, 41044, 41048, 41057, 41059, 41066, 41067, 41077, 41083, 41092, 41094, 41095, 41097, 41098, 41134, 41148, 41149, 41154, 41158, 41166, 41171, 41195, 41197, 41198, 41203, 41205, 41206, 41208, 41209, 41212, 41221, 41222, 41237, 41250, 41251, 41260, 41265, 41278, 41290, 41294, 41305, 41313, 41358, 41406, 41409, 41415, 41418, 41420, 41421, 41426, 41429, 41463, 41481, 41482, 41495, 41511, 41512, 41514, 41517, 41525, 41532, 41551, 41552, 41555, 41569, 41580, 41224, 41238, 41319, 41526, 41118; 4. Model Numbers (REF): 782101(1.5T); UDI-DI: 884838098275; Serial Numbers: 87602, 87644, 87645, 87648, 87649, 87653, 87601, 87605, 87298, 87607, 87608, 87609, 87610, 87612, 87613, 87614, 87617, 87627, 87631, 87632, 87633, 87634, 87635, 87636, 87638, 87639, 87640, 87641, 87642, 87643, 87654, 87655; 5. Model Numbers (REF): 782115(1.5T); UDI-DI: 884838099043; Serial Numbers: 61250, 61281, 61361, 61362, 61363, 61364, 61365, 61366, 61367, 61368, 61369, 61370, 61371, 61372, 61373, 61374, 61375, 61376, 61377, 61213, 61214, 61280, 61299, 61341, 61292, 61358, 61385, 61266, 61201, 61210, 61212, 61217, 61227, 61350, 61403, 61417, 61264, 61273, 61192, 61193, 61246, 61206, 61208, 61219, 61248, 61249, 61265, 61269, 61328, 61337, 61257, 61425, 61303, 61306, 61316, 61320, 61321, 61348, 61349, 61354, 61355, 61356, 61357, 61360, 61378, 61404, 61419, 61420, 61421, 61332, 61175, 61181, 61182, 61183, 61188, 61199, 61200, 61204, 61218, 61220, 61224, 61268, 61270, 61289, 61295, 61300, 61334, 61338, 61390, 61393, 61394, 61395, 61396, 61397, 61398, 61400, 61408, 61409, 61410, 61411, 61413, 61422, 61428, 61177, 61180, 61184, 61185, 61187, 61189, 61191, 61205, 61209, 61221, 61222, 61225, 61229, 61230, 61237, 61243, 61245, 61253, 61262, 61263, 61275, 61279, 61313, 61314, 61315, 61336, 61288, 61352, 61416, 61179, 61258, 61359, 61304, 61380, 61145, 61196, 61381, 61426, 61407, 61415, 61427, 61232, 61223, 61298, 61195, 61226, 61351, 61333, 61339, 61252, 61234, 61203, 61235, 61329, 61241, 61326, 61327, 61176, 61198, 61202, 61211, 61240, 61256, 61283, 61285, 61290, 61293, 61294, 61302, 61406, 61207, 61233, 61242, 61282, 61331, 61342, 61383, 61384, 61310, 61311, 61312, 61259, 61260; 6. Model Numbers (REF): 782140(1.5T); UDI-DI: 884838108646; Serial Numbers: 45607, 45606, 45608, 45609, 45610, 45601; 7. Model Numbers (REF): 781261(1.5T CX); UDI-DI: 884838068445; Serial Numbers: 77008, 77000, 77004, 77001, 77019, 77010, 77014, 77007, 77016; 8. Model Numbers (REF): 781262(1.5T CX); UDI-DI: 884838068445; Serial Numbers: 77131, 77070, 77124, 77144, 77172, 77074, 77048, 77178, 77031, 77134, 77050, 77051, 77060, 77194, 77034, 77037, 77038, 77057, 77072, 77075, 77078, 77084, 77085, 77086, 77092, 77101, 77110, 77156, 77157, 77111, 77119, 77167, 77183, 77185, 77187, 77188, 77195, 77196, 77198, 77199, 77202, 77052, 77053, 77054, 77055, 77056, 77064, 77065, 77066, 77067, 77068, 77069, 77105, 77125, 77126, 77135, 77136, 77137, 77138, 77139, 77148, 77141, 77030, 77032, 77033, 77036, 77042, 77043, 77044, 77049, 77059, 77061, 77071, 77083, 77087, 77088, 77090, 77091, 77093, 77097, 77100, 77106, 77107, 77115, 77118, 77120, 77121, 77128, 77155, 77161, 77162, 77190, 77140, 77201, 77166, 77045, 77063, 77109, 77117, 77123, 77147, 77113, 77168, 77169, 77122, 77154, 77046, 77130, 77062, 77039, 77040, 77114, 77127, 77160, 77150, 77041, 77193, 77203; 9. Model Numbers (REF): 781347(1.5T S); UDI-DI: 884838068421; Serial Numbers: 81003, 81050, 81051, 81090, 81111, 81151, 81010, 81028, 81030, 81035, 81063, 81106, 81093, 81105, 81116, 81004, 81009, 81011, 81017, 81018, 81019, 81020, 81023, 81024, 81031, 81037, 81041, 81055, 81056, 81060, 81064, 81070, 81074, 81078, 81112, 81115, 81118, 81122, 81138, 81139, 81140, 81146, 81147, 81153, 81156, 81158, 81175, 81184, 81013, 81044, 81005, 81007, 81040, 81047, 81059, 81167, 81170, 81171, 81008, 81108, 81148, 81133, 81164, 81001, 81026, 81086, 81079, 81014, 81061, 81065, 81085, 81091, 81092, 81032, 81043, 81129, 81131, 81149, 81155, 81162, 81165, 81172, 81084, 81087, 81088, 81094, 81095, 81127, 81132, 81174, 81157, 81176, 81071, 81052, 81067, 81038, 81179, 81185, 81117, 81173, 81154, 81025, 81097, 81045, 81075, 81076, 81077, 81096, 81114, 81124, 81126, 81145, 81159, 81152, 81029, 81034, 81042, 81049, 81058, 81080, 81113, 81123, 81128, 81137, 81178;

   Quantity

   2038

   Classification

   Class II

6. Ingenia Ambition S and Ingenia Ambition X; Model Numbers (REF): 1. 781359 (S), 2. 782108 (S), 3. 782139 (S), 4. 781356 (X), 5. 782109 (X), 6. 782138 (X);

   FDA recall number

   Z-3237-2026

   Codes, lots and dates

   1. Model Numbers (REF): 781359(S); UDI-DI: 884838090057; Serial Numbers: 48053, 48126, 48136, 48144, 48020, 48030, 48155, 48191, 48216, 48218, 48245, 48300, 48183, 48186, 48187, 48222, 48225, 48234, 48240, 48241, 48249, 48269, 48278, 48284, 48288, 48293, 48294, 48299, 48304, 48313, 48317, 48326, 48331, 48051, 48223, 48207, 48028, 48031, 48049, 48050, 48131, 48134, 48242, 48254, 48219, 48000, 48004, 48019, 48032, 48132, 48135, 48145, 48160, 48224, 48244, 48040, 48122, 48039, 48022, 48152, 48012, 48014, 48036, 48037, 48044, 48127, 48151, 48158, 48174, 48184, 48046, 48047, 48055, 48128, 48129, 48153, 48190, 48192, 48194, 48226, 48275, 48181, 48198, 48199, 48200, 48033, 48045, 48001, 48038, 48185, 48238, 48239, 48276, 48010, 48170, 48035, 48172, 48027, 48248, 48146, 48147, 48148, 48163, 48164, 48165, 48169, 48182, 48188, 48271, 48290, 48291, 48297, 48302, 48303, 48308, 48309, 48310, 48321, 48325, 48329, 48337, 48018, 48283, 48177, 48017, 48056, 48250, 48272, 48253, 48268, 48026, 48013, 48052, 48112, 48120, 48130, 48162, 48171, 48179, 48214, 48217, 48233, 48237, 48243, 48252, 48273, 48274, 48286, 48287, 48314, 48322, 48133, 48316; 2. Model Numbers (REF): 782108(S); UDI-DI: 884838098343; Serial Numbers: 48572, 48627, 48581, 48687, 48592, 48652, 48800, 48953, 48544, 48506, 48520, 48521, 48534, 48551, 48781, 48834, 48842, 48843, 48848, 48892, 48712, 48714, 48715, 48810, 48813, 48833, 48883, 48885, 48943, 48947, 48538, 48539, 48556, 48602, 48640, 48808, 48613, 48650, 48502, 48507, 48514, 48540, 48577, 48579, 48580, 48590, 48591, 48612, 48614, 48617, 48620, 48628, 48632, 48638, 48692, 48697, 48698, 48721, 48765, 48818, 48819, 48824, 48503, 48557, 48570, 48595, 48606, 48651, 48706, 48707, 48725, 48729, 48744, 48756, 48773, 48796, 48804, 48815, 48861, 48876, 48898, 48695, 48660, 48734, 48877, 48878, 48879, 48679, 48889, 48529, 48609, 48622, 48658, 48659, 48769, 48774, 48837, 48857, 48864, 48574, 48900, 48541, 48549, 48710, 48865, 48504, 48508, 48513, 48524, 48536, 48537, 48555, 48560, 48571, 48573, 48585, 48593, 48594, 48596, 48597, 48600, 48611, 48624, 48639, 48642, 48644, 48666, 48711, 48762, 48768, 48775, 48778, 48891, 48950, 48522, 48561, 48668, 48686, 48737, 48846, 48852, 48887, 48607, 48519, 48680, 48699, 48738, 48820, 48845, 48860, 48867, 48868, 48869, 48870, 48901, 48942, 48948, 48951, 48958, 48962, 48532, 48533, 48505, 48567, 48671, 48672, 48676, 48801, 48604, 48851, 48515, 48584, 48886, 48674, 48753, 48754, 48782, 48783, 48784, 48785, 48789, 48790, 48791, 48793, 48794, 48807, 48875, 48902, 48945, 48941, 48961, 48550, 48647, 48850, 48610, 48615, 48654, 48728, 48685, 48817, 48500, 48635, 48523, 48535, 48546, 48552, 48562, 48578, 48589, 48645, 48646, 48648, 48649, 48655, 48656, 48665, 48669, 48675, 48700, 48708, 48719, 48748, 48749, 48826, 48827, 48828, 48832, 48855, 48872, 48874, 48888, 48907, 48973, 48661, 48662, 48663, 48724, 48693, 48884, 48525, 48526, 48978; 3. Model Numbers (REF): 782139(S); UDI-DI: 884838108639; Serial Numbers: 29021, 29038, 29000, 29008, 29010, 29011, 29012, 29014, 29016, 29022, 29039, 29040, 29045, 29052, 29072, 29096, 29097, 29105, 29108, 29127, 29130, 29131, 29081, 29090, 29095, 29151, 29054, 29069, 29078, 29115, 29053, 29118, 29139, 29140, 29003, 29015, 29020, 29028, 29033, 29143, 29169, 29013, 29138, 29144, 29062, 29076, 29079, 29126, 29132, 29137, 29153, 29155, 29157, 29158, 29164, 29136, 29150, 29160, 29068, 29070, 29165, 29120, 29057, 29047, 29049, 29133, 29134, 29042, 29043, 29055, 29065, 29122; 4. Model Numbers (REF): 781356(X); UDI-DI: 884838090040; Serial Numbers: 47194, 47040, 47091, 47345, 47361, 47050, 47209, 47254, 47275, 47049, 47357, 47013, 47014, 47015, 47053, 47065, 47082, 47000, 47002, 47017, 47024, 47035, 47047, 47056, 47058, 47074, 47078, 47089, 47192, 47225, 47337, 47226, 47227, 47341, 47307, 47364, 47365, 47372, 47284, 47350, 47057, 47075, 47088, 47174, 47175, 47193, 47052, 47085, 47262, 47328, 47342, 47384, 47064, 47244, 47219, 47220, 47298, 47247, 47329, 47096, 47207, 47283, 47190, 47264, 47034, 47202, 47315, 47332, 47367, 47385, 47016, 47269, 47382, 47352, 47021, 47001, 47032, 47041, 47248, 47255, 47311, 47272, 47306, 47077, 47009, 47080, 47083, 47242, 47245, 47302, 47310, 47312, 47006, 47007, 47011, 47018, 47022, 47025, 47028, 47033, 47044, 47045, 47054, 47060, 47061, 47062, 47066, 47071, 47084, 47090, 47093, 47095, 47176, 47183, 47185, 47196, 47198, 47203, 47204, 47205, 47208, 47210, 47216, 47251, 47280, 47291, 47316, 47323, 47324, 47325, 47330, 47331, 47333, 47335, 47336, 47338, 47339, 47340, 47346, 47370, 47377, 47378, 47380, 47387; 5. Model Numbers (REF): 782109(X); UDI-DI: 884838098350; Serial Numbers: 47531, 47540, 47877, 47878, 47879, 47869, 47519, 47526, 47555, 47584, 47839, 47565, 47644, 47742, 47585, 47582, 47755, 47903, 47928, 47935, 47940, 47713, 47946, 47947, 47944, 47507, 47508, 47610, 47900, 47901, 47527, 47529, 47545, 47640, 47725, 47778, 47855, 47858, 47870, 47532, 47533, 47547, 47548, 47591, 47831, 47843, 47882, 47607, 47583, 47625, 47626, 47627, 47628, 47629, 47630, 47675, 47676, 47786, 47850, 47854, 47868, 47921, 47933, 47509, 47525, 47765, 47902, 47908, 47919, 47504, 47579, 47683, 47688, 47737, 47784, 47808, 47809, 47810, 47822, 47826, 47837, 47846, 47847, 47887, 47905, 47909, 47910, 47936, 47938, 47939, 47511, 47536, 47543, 47561, 47562, 47564, 47646, 47671, 47681, 47694, 47698, 47750, 47603, 47705, 47578, 47819, 47516, 47841, 47907, 47954, 47955, 47956, 47957, 47958, 47959, 47937, 47518, 47716, 47754, 47782, 47783, 47689, 47853, 47952, 47953, 47656, 47867, 47912, 47914, 47798, 47948, 47665, 47557, 47834, 47550, 47513, 47602, 47528, 47768, 47770, 47773, 47804, 47860, 47883, 47889, 47785, 47791, 47934, 47635, 47788, 47906, 47923, 47696, 47747, 47806, 47865, 47535, 47614, 47617, 47651, 47652, 47660, 47661, 47662, 47663, 47718, 47720, 47721, 47727, 47728, 47729, 47730, 47731, 47779, 47851, 47560, 47546, 47563, 47697, 47797, 47811, 47845, 47904, 47566, 47597, 47679, 47695, 47753, 47577, 47701, 47738, 47514, 47632, 47792, 47538, 47554, 47574, 47575, 47576, 47621, 47642, 47659, 47672, 47739, 47740, 47759, 47763, 47771, 47794, 47799, 47802, 47813, 47814, 47823, 47835, 47859, 47861, 47888, 47891, 47896, 47929, 47931, 47950; 6. Model Numbers (REF): 782138(X); UDI-DI: 884838108622; Serial Numbers: 49004, 49049, 49106, 49136, 49063, 49075, 49183, 49197, 49246, 49269, 49272, 49020, 49021, 49022, 49027, 49029, 49030, 49031, 49033, 49034, 49036, 49037, 49038, 49039, 49043, 49055, 49060, 49068, 49069, 49140, 49189, 49190, 49191, 49192, 49194, 49195, 49196, 49202, 49203, 49219, 49221, 49223, 49230, 49251, 49254, 49255, 49045, 49058, 49071, 49130, 49153, 49158, 49180, 49181, 49270, 49145, 49161, 49168, 49156, 49228, 49047, 49098, 49099, 49147, 49148, 49154, 49220, 49222, 49232, 49268, 49206, 49290, 49008, 49009, 49092, 49093, 49094, 49146, 49072, 49080, 49087, 49104, 49105, 49109, 49173, 49210, 49231, 49233;

   Quantity

   922

   Classification

   Class II

7. Ingenia 3.0T and Ingenia 3.0T CX; Model Numbers (REF): 1. 781342(3.0T), 2. 781377(3.0T), 3. 782103(3.0T), 4. 781271(3.0T CX), 5. 782105(3.0T CX);

   FDA recall number

   Z-3238-2026

   Codes, lots and dates

   1. Model Numbers (REF): 781342(3.0T); UDI-DI: 884838055339; Serial Numbers: 85106, 71152, 71526, 71812, 71179, 71252, 71328, 71342, 71419, 71550, 71551, 71555, 71557, 71674, 71693, 71949, 85036, 85155, 71266, 71345, 71392, 71395, 71628, 85393, 71216, 71651, 85208, 71163, 71408, 71499, 71541, 71668, 71771, 71602, 71260, 71276, 71324, 71726, 71068, 71300, 71482, 71339, 71452, 71464, 71465, 71468, 71470, 71471, 71472, 71473, 71479, 71480, 71492, 71497, 71506, 71509, 71511, 71514, 71516, 71517, 71519, 71520, 71548, 71553, 71554, 71559, 71560, 71567, 71588, 71596, 71601, 71605, 71609, 71614, 71621, 71622, 71624, 71626, 71629, 71631, 71633, 71637, 71642, 71653, 71654, 71685, 71687, 71690, 71692, 71695, 71698, 71699, 71702, 71707, 71708, 71709, 71713, 71714, 71716, 71734, 71738, 71744, 71755, 71765, 71775, 71779, 71783, 71784, 71786, 71788, 71804, 71807, 71814, 71818, 71819, 71820, 71821, 71834, 71839, 71840, 71856, 71861, 71868, 71872, 71875, 71876, 71877, 71894, 71898, 71908, 71913, 71917, 71928, 71930, 71935, 71944, 71946, 71951, 71952, 71957, 71958, 71973, 71987, 71988, 85010, 85024, 85026, 85028, 85037, 85042, 85048, 85049, 85050, 85061, 85065, 85073, 85075, 85079, 85096, 85098, 85099, 85105, 85111, 85112, 85127, 85141, 85152, 85153, 85160, 85162, 85168, 85169, 85170, 85171, 85172, 85174, 85177, 85178, 85184, 85198, 85200, 85204, 85218, 85220, 85226, 85230, 85242, 85243, 85247, 85249, 85251, 85259, 85263, 85268, 85269, 85270, 85272, 85280, 85282, 85283, 85284, 85285, 85288, 85290, 85291, 85294, 85300, 85303, 85305, 85309, 85310, 85311, 85313, 85314, 85323, 85325, 85329, 85332, 85333, 85334, 85335, 85336, 85339, 85344, 85345, 85346, 85349, 85350, 85351, 85353, 85354, 85355, 85356, 85357, 85358, 85359, 85360, 85361, 85362, 85364, 85369, 85370, 85371, 85373, 85374, 85375, 85376, 85380, 85382, 85383, 85384, 85385, 85386, 85387, 85389, 85390, 85392, 85397, 85398, 85399, 85401, 85402, 85403, 85406, 85407, 85408, 85412, 85413, 85415, 85416, 85417, 85418, 85419, 85420, 85422, 85425, 85426, 85427, 85429, 85430, 85431, 85432, 85433, 85434, 85439, 85440, 85442, 85447, 85448, 85449, 85453, 85454, 85455, 85456, 85457, 85458, 85460, 85461, 85462, 85463, 85466, 85467, 85468, 85469, 85470, 85471, 85476, 85478, 85479, 85480, 85481, 85483, 85484, 85485, 85487, 85488, 85490, 85491, 85494, 85496, 85497, 85498, 85499, 85501, 85504, 85506, 85507, 85509, 85510, 85515, 85517, 85518, 85519, 85522, 85524, 85525, 85526, 85527, 85528, 85531, 85532, 85533, 85535, 71372, 71649, 71581, 71582, 71748, 85143, 71405, 71373, 85265, 71047, 71662, 71678, 71891, 85189, 71267, 71353, 71402, 71457, 85450, 85451, 71474, 71338, 71418, 71924, 71991, 85202, 85306, 71437, 71003, 71020, 71023, 71173, 71192, 71283, 71288, 71298, 71315, 71337, 71359, 71363, 71370, 71396, 71400, 71440, 71501, 71576, 71590, 71603, 71751, 71791, 71838, 71874, 85025, 85161, 85253, 85301, 85319, 85342, 85391, 71346, 71362, 71910, 71983, 85063, 85183, 85205, 85206, 85216, 85341, 71334, 71409, 71476, 85023, 71061, 71106, 71162, 71165, 71181, 71280, 71349, 71351, 71357, 71410, 71428, 71460, 71477, 71512, 71518, 71643, 71677, 71691, 71717, 71743, 71750, 71762, 71763, 71842, 71854, 71900, 71966, 71967, 85122, 85140, 85147, 85149, 85190, 85203, 85210, 85224, 85318, 71367, 71461, 71545, 85241, 85302, 85348, 85372, 85459, 71423, 71177, 71326, 71424, 71681, 71758, 71863, 71892, 85057, 85245, 85246, 85250, 85286, 71001, 71002, 71004, 71007, 71012, 71013, 71014, 71035, 71037, 71039, 71056, 71070, 71093, 71095, 71154, 71155, 71174, 71175, 71183, 71211, 71228, 71268, 71269, 71282, 71341, 71347, 71361, 71401, 71411, 71413, 71416, 71425, 71429, 71450, 71463, 71489, 71498, 71527, 71571, 71587, 71589, 71592, 71635, 71641, 71652, 71655, 71659, 71670, 71676, 71682, 71686, 71694, 71760, 71766, 71767, 71772, 71778, 71801, 71802, 71825, 71844, 71851, 71864, 71869, 71878, 71879, 71880, 71881, 71882, 71897, 71972, 71992, 85022, 85038, 85064, 85069, 85074, 85076, 85083, 85121, 85124, 85217, 85377, 85378, 85381, 85396, 85400, 71086, 71343, 71671, 71679, 85428, 71107, 85166, 71058, 71078, 71176, 71263, 71299, 71307, 71321, 71387, 71575, 71625, 71640, 71799, 71852, 85181, 85187, 85312, 85330, 85365, 71172, 71195, 71790, 71948, 71996, 85004, 85136, 85223, 85317, 85109, 71956, 85232, 85304, 85021, 71159, 71364, 71380, 71563, 71953, 71170, 71296, 71781, 85213, 71097, 71722, 71335, 71919, 85148, 85367, 71302, 85366, 71150, 71188, 71225, 71360, 71634, 71665, 71884, 85009, 71510, 71746, 85018, 71648, 85236, 85260, 85368, 71220, 71227, 71272, 71350, 71451, 71522, 71700, 85012, 85054, 85316, 85388, 85414, 71077, 71204, 71365, 71398, 85091, 71478, 71618, 71826, 71669, 71764, 71833, 71867, 71270, 71051, 71231, 71604, 71650, 71689, 71823, 71895, 85059, 85321, 85340, 71600, 71848, 71305, 71445, 71566, 71018, 71040, 71072, 71189, 71197, 71198, 71224, 71332, 71384, 71434, 71442, 71448, 71486, 71496, 71597, 71623, 71644, 71645, 71703, 71706, 71737, 71752, 71871, 85081, 85114, 85142, 71314, 71583, 71808, 71916, 71291, 71304, 71368, 71371, 71711, 71756, 71822, 71860, 71911, 71931, 71936, 85123, 85125, 85185, 85193, 71333, 71377, 71386, 71524, 71785, 71789, 71986, 85019, 85209, 85295, 85322, 71352, 71426, 71977, 85020, 71215, 71285, 71287, 71308, 71318, 71354, 71459, 71490, 71534, 85101, 71010, 71016, 71022, 71029, 71045, 71062, 71064, 71065, 71071, 71073, 71153, 71187, 71190, 71194, 71200, 71203, 71213, 71275, 71277, 71317, 71319, 71331, 71336, 71369, 71376, 71379, 71382, 71388, 71397, 71399, 71407, 71415, 71444, 71456, 71483, 71495, 71528, 71529, 71569, 71570, 71584, 71599, 71667, 71675, 71680, 71683, 71721, 71732, 71735, 71796, 71805, 71810, 71827, 71829, 71858, 71893, 71914, 71982, 85067, 85094, 85154, 85221, 85275, 85278, 85436, 71436, 85222, 71544; 2. Model Numbers (REF): 781377(3.0T); UDI-DI: 884838009813; Serial Numbers: 42175, 42190, 42221, 42231, 42283, 42291, 42339, 42439, 42466, 42186, 42147, 42171, 42183, 42206, 42213, 42448, 42243, 42251, 42280, 42326, 42343, 42362, 42367, 42380, 42398, 42436, 42444, 42445, 42446, 42452, 42453, 42454, 42458, 42459, 42463, 42469, 42490, 42491, 42492, 42493, 42494, 42495, 42496, 42499, 42500, 42502, 42504, 42505, 42506, 42507, 42508, 42510, 42512, 42520, 42522, 42525, 42528, 42530, 42531, 42545, 42546, 42547, 42548, 42549, 42552, 42553, 42554, 42555, 42556, 42557, 42558, 42560, 42561, 42565, 42570, 42042, 42239, 42178, 42041, 42092, 42005, 42013, 42015, 42021, 42027, 42028, 42061, 42073, 42081, 42082, 42090, 42097, 42107, 42130, 42138, 42141, 42143, 42145, 42216, 42279, 42292, 42315, 42044, 42089, 42232, 42272, 42026, 42047, 42110, 42146, 42191, 42192, 42285, 42364, 42407, 42426, 42136, 42137, 42199, 42275, 42014, 42056, 42074, 42093, 42095, 42103, 42112, 42115, 42121, 42128, 42133, 42161, 42162, 42179, 42203, 42205, 42222, 42233, 42237, 42245, 42249, 42252, 42253, 42257, 42260, 42261, 42262, 42263, 42278, 42282, 42289, 42300, 42309, 42314, 42331, 42333, 42337, 42345, 42347, 42349, 42361, 42378, 42383, 42392, 42412, 42420, 42421, 42422, 42432, 42442, 42428, 42087, 42120, 42170, 42201, 42267, 42401, 42449, 42294, 42019, 42390, 42451, 42135, 42209, 42008, 42236, 42353, 42355, 42455, 42256, 42043, 42438, 42265, 42321, 42018, 42012, 42065, 42079, 42132, 42134, 42176, 42303, 42338, 42399, 42419, 42264, 42131, 42204, 42055, 42220, 42358, 42413, 42001, 42006, 42034, 42036, 42038, 42040, 42045, 42050, 42052, 42053, 42067, 42068, 42076, 42083, 42096, 42099, 42100, 42101, 42102, 42111, 42116, 42117, 42119, 42123, 42150, 42152, 42169, 42177, 42180, 42185, 42214, 42229, 42240, 42241, 42242, 42247, 42266, 42274, 42286, 42298, 42307, 42328, 42334, 42356, 42365, 42368, 42370, 42389, 42400, 42429, 42077, 42066; 3. Model Numbers (REF): 782103(3.0T); UDI-DI: 884838098299; Serial Numbers: 85724, 85667, 85622, 85625, 85626, 85628, 85629, 85630, 85631, 85633, 85636, 85637, 85638, 85641, 85642, 85650, 85656, 85657, 85658, 85659, 85660, 85662, 85692, 85710, 85715, 85721, 85722, 85725, 85727, 85729, 85735, 85738, 85739, 85740, 85743, 85745, 85746, 85747, 85748, 85749, 85756, 85696, 85620, 85608, 85614, 85755, 85672, 85673, 85674, 85720, 85730, 85732, 85762, 85693, 85619, 85718, 85600, 85607, 85616, 85617, 85707, 85613, 85611, 85612, 85615, 85703, 85719, 85666, 85664, 85700, 85643, 85644, 85761; 4. Model Numbers (REF): 781271(3.0T CX); UDI-DI: 884838068452; Serial Numbers: 78121, 78150, 78157, 78096, 78012, 78074, 78154, 78161, 78170, 78171, 78172, 78173, 78182, 78183, 78189, 78190, 78196, 78198, 78205, 78210, 78212, 78213, 78216, 78218, 78221, 78225, 78240, 78242, 78243, 78244, 78250, 78251, 78252, 78253, 78256, 78257, 78262, 78263, 78265, 78266, 78267, 78268, 78269, 78270, 78271, 78272, 78273, 78279, 78280, 78281, 78282, 78283, 78284, 78288, 78289, 78291, 78292, 78293, 78294, 78295, 78296, 78301, 78305, 78306, 78307, 78308, 78309, 78310, 78312, 78313, 78314, 78316, 78317, 78319, 78320, 78321, 78322, 78323, 78327, 78328, 78329, 78330, 78332, 78333, 78334, 78335, 78338, 78339, 78340, 78341, 78342, 78343, 78345, 78346, 78347, 78352, 78353, 78354, 78356, 78357, 78358, 78359, 78360, 78361, 78362, 78363, 78364, 78366, 78368, 78370, 78374, 78375, 78376, 78377, 78386, 78078, 78224, 78098, 78003, 78065, 78070, 78076, 78081, 78087, 78097, 78099, 78101, 78104, 78107, 78126, 78149, 78151, 78181, 78206, 78219, 78264, 78064, 78106, 78187, 78000, 78007, 78010, 78015, 78018, 78019, 78021, 78023, 78029, 78031, 78032, 78038, 78039, 78043, 78048, 78049, 78051, 78062, 78068, 78072, 78082, 78083, 78084, 78088, 78089, 78091, 78095, 78100, 78109, 78111, 78117, 78127, 78129, 78132, 78133, 78139, 78140, 78155, 78203, 78207, 78214, 78222, 78223, 78011, 78013, 78014, 78034, 78044, 78046, 78047, 78058, 78060, 78066, 78071, 78073, 78075, 78077, 78086, 78092, 78102, 78110, 78118, 78120, 78128, 78135, 78137, 78138, 78141, 78142, 78158, 78162, 78164, 78180, 78188, 78193, 78194, 78209, 78215, 78227, 78232, 78234, 78247, 78254, 78255, 78261, 78277, 78290, 78297, 78298, 78299, 78326, 78337, 78004, 78030, 78059, 78156, 78249, 78026, 78022; 5. Model Numbers (REF): 782105(3.0T CX); UDI-DI: 884838098312; Serial Numbers: 78516, 78517, 78518, 78519, 78521, 78522, 78523, 78524, 78525, 78526, 78527, 78528, 78529, 78530, 78531, 78536, 78537, 78539, 78545, 78546, 78547, 78548, 78549, 78550, 78551, 78553, 78554, 78555, 78556, 78557, 78558, 78559, 78560, 78561, 78562, 78564, 78565, 78567, 78570, 78571, 78573, 78574, 78500, 78501, 78503, 78504, 78505, 78507, 78508, 78512, 78513, 78532, 78535, 78538, 78540, 78541, 78542, 78543, 78544, 78552, 78566, 78568;

   Quantity

   1447

   Classification

   Class II

8. Ingenia Elition S and Ingenia Elition X; Model Numbers (REF): 1. 781357(S), 2. 782106(S), 3. 782137(S), 4. 781358(X), 5. 782107(X), 6. 782119(X), 7. 782136(X), 8. 782158(X);

   FDA recall number

   Z-3239-2026

   Codes, lots and dates

   1. Model Numbers (REF): 781357(S); UDI-DI: 884838088108; Serial Numbers: 46083, 46045, 46095, 46119, 46121, 46024, 46044, 46055, 46061, 46052, 46001, 46005, 46011, 46048, 46057, 46060, 46066, 46078, 46081, 46016, 46026, 46032, 46033, 46037, 46046, 46054, 46058, 46059, 46068, 46069, 46075, 46082, 46003, 46019, 46111, 46007, 46107, 46067, 46093, 46030, 46031, 46049, 46050, 46089, 46014, 46065, 46071, 46077, 46088, 46109; 2. Model Numbers (REF): 782106(S); UDI-DI: 884838098329; Serial Numbers: 46247, 46250, 46316, 46376, 46200, 46368, 46324, 46331, 46338, 46363, 46367, 46383, 46394, 46398, 46399, 46400, 46201, 46202, 46220, 46225, 46352, 46310, 46234, 46205, 46207, 46209, 46211, 46214, 46215, 46226, 46228, 46235, 46237, 46239, 46240, 46241, 46282, 46281, 46297, 46304, 46317, 46354, 46212, 61010, 46206, 46362, 46393, 46348, 46217, 46289, 46233, 46353, 46213, 46218, 46222, 46384, 46224, 46265, 46286, 46390, 46263, 46307, 46387, 46403; 3. Model Numbers (REF): 782137(S); UDI-DI: 884838108615; Serial Numbers: 64004, 64008, 64024, 64028, 64031, 64046, 64047, 64002, 64003, 64009, 64013, 64034, 64045, 64050, 64030, 64029, 64049, 64051; 4. Model Numbers (REF): 781358(X); UDI-DI: 884838088115; Serial Numbers: 45107, 45142, 45145, 45216, 45241, 45284, 45121, 45257, 45154, 45193, 45253, 45106, 45131, 45259, 45298, 45300, 45302, 45313, 45330, 45344, 45345, 45349, 45352, 45359, 45360, 45363, 45367, 45368, 45370, 45371, 45372, 45377, 45378, 45381, 45390, 45391, 45394, 45396, 45397, 45409, 45410, 45411, 45412, 45416, 45417, 45419, 45421, 45428, 45432, 45434, 45435, 45437, 45439, 45442, 45443, 45444, 45446, 45447, 45448, 45450, 45451, 45456, 45459, 45461, 45463, 45467, 45469, 45470, 45471, 45473, 45474, 45476, 45480, 45265, 45293, 45369, 45159, 45374, 45040, 45065, 45070, 45260, 45319, 45000, 45039, 45047, 45080, 45109, 45137, 45188, 45210, 45262, 45339, 45139, 45025, 45031, 45114, 45151, 45160, 45176, 45248, 45274, 45276, 45282, 45392, 45438, 45441, 45138, 45041, 45046, 45050, 45061, 45064, 45066, 45076, 45077, 45102, 45118, 45141, 45149, 45163, 45170, 45185, 45189, 45211, 45212, 45224, 45250, 45268, 45272, 45280, 45281, 45314, 45323, 45332, 45340, 45295, 45122, 45123, 45169, 45192, 45203, 45204, 45207, 45220, 45228, 45229, 45249, 45278, 45279, 45320, 45354, 45267, 45085, 45311, 45312, 45156, 45157, 45292, 45009, 45181, 45217, 45289, 45348, 45362, 45219, 45094, 45180, 45067, 45183, 45393, 45408, 45426, 45081, 45095, 45376, 45058, 45140, 45294, 45042, 45195, 45197, 45242, 45350, 45174, 45165, 45382, 45158, 45177, 45153, 45088, 45111, 45128, 45134, 45218, 45002, 45010, 45027, 45051, 45068, 45082, 45087, 45124, 45133, 45147, 45161, 45164, 45178, 45237, 45238, 45245, 45247, 45261, 45269, 45277, 45296, 45315, 45321, 45322, 45337, 45338, 45343, 45353, 45355, 45356, 45357, 45364, 45414, 45429, 45155; 5. Model Numbers (REF): 782107(X); UDI-DI: 884838098336; Serial Numbers: 62016, 62189, 45525, 45551, 45546, 45590, 62158, 62180, 62103, 62104, 62106, 62107, 62108, 62109, 62110, 62111, 62112, 62113, 62114, 62115, 62117, 62118, 62119, 62120, 62122, 62124, 62125, 62126, 62127, 62132, 62133, 62138, 62142, 62162, 62163, 62164, 62167, 62170, 62173, 62176, 62187, 62196, 62200, 62201, 62202, 62203, 62204, 62209, 62210, 62211, 62213, 62216, 62223, 62225, 62226, 62227, 62228, 62230, 62232, 62239, 62243, 62244, 62245, 62247, 45555, 62130, 62018, 62087, 62091, 45568, 62207, 62219, 45523, 45536, 45542, 62214, 45540, 45577, 62046, 62100, 62139, 62217, 45566, 45562, 45567, 45587, 45595, 62012, 62029, 62031, 62128, 62154, 62155, 62166, 62184, 62190, 62205, 62206, 62240, 62254, 62255, 62256, 62264, 62265, 45596, 45599, 62021, 62186, 45594, 45528, 45529, 45538, 45560, 45564, 62024, 62041, 62047, 62048, 62070, 62084, 62137, 62179, 62168, 45501, 45511, 45516, 45517, 45518, 45556, 45565, 62017, 62039, 62090, 62236, 62231, 45554, 62145, 62146, 62224, 62258, 62259, 62260, 62261, 62262, 62263, 62266, 45520, 45583, 62066, 62212, 62038, 62156, 62157, 62215, 62140, 62188, 62148, 45544, 45579, 62035, 62050, 62058, 62059, 62061, 62062, 62065, 62071, 62097, 62134, 45524, 45550, 62042, 45521, 45600, 45504, 45531, 45563, 45570, 62026, 62152, 62183, 62208, 62218, 62241; 6. Model Numbers (REF): 782119(X); UDI-DI: 884838104129; Serial Numbers: 66002, 66001; 7. Model Numbers (REF): 782136(X); UDI-DI: 884838108608; Serial Numbers: 28514, 28576, 28569, 28502, 28536, 28567, 28588, 28613, 28585, 28533, 28544, 28573, 28615, 28629, 28555, 28504, 28516, 28517, 28524, 28531, 28537, 28563, 28575, 28591, 28592, 28593, 28594, 28595, 28596, 28597, 28598, 28599, 28554, 28635, 28636, 28506, 28509, 28565, 28581, 28625, 28628, 28638, 28527, 28550, 28586, 28604, 28616; 8. Model Numbers (REF): 782158(X); UDI-DI: 884838115699; Serial Number: 90017;

   Quantity

   596

   Classification

   Class II

9. Name (Model Number): 1. Intera 1.5T (781195), 2. Intera 1.5T (781295), 3. Intera 1.5T Achieva IT Nova (781175), 4. Intera 1.5T Achieva Nova (781172), 5. Intera 1.5T Achieva Nova-Dual (781173), 6. Intera 1.5T Omni/Stellar (781104), 7. Intera Achieva 1.5T Pulsar (781171);

   FDA recall number

   Z-3240-2026

   Codes, lots and dates

   1. Intera 1.5T Model Numbers (REF): 781195; UDI-DI: N/A; Serial Numbers: 18774, 18781, 18951, 18958, 18962, 18971, 20431, 18898, 20429, 18669, 18981, 18982, 18734, 18763, 20427, 18842, 18654, 18878, 18566, 18618, 18752, 20409, 18748, 18743, 18657, 20424, 18755, 18908, 18501, 18646, 18768, 18516, 18554, 18616, 18723, 18725, 18784; 2. Intera 1.5T; Model Numbers (REF): 781295; UDI-DI: N/A; Serial Numbers: 30138, 30297, 30314, 30210, 30137, 30173, 30179, 30104, 30105, 30290, 30208, 30051, 30035, 30143, 30109, 30063, 30237, 30135; 3. Intera 1.5T Achieva IT Nova; Model Numbers (REF): (781175); UDI-DI: N/A; Serial Number: 15003; 4. Intera 1.5T Achieva Nova; Model Numbers (REF): 781172; UDI-DI: N/A; Serial Numbers: 12105, 12049, 12079, 12001, 12086, 12099, 12046, 12057, 12081, 12075, 12078, 12106; 5. Intera 1.5T Achieva Nova-Dual; Model Numbers (REF): 781173; UDI-DI: N/A; Serial Numbers: 13006, 13017, 13058, 13012, 13048, 13049; 6. Intera 1.5T Omni/Stellar; Model Numbers (REF): 781104; UDI-DI: N/A; Serial Number: 10403; 7. Intera Achieva 1.5T Pulsar; Model Numbers (REF): 781171; UDI-DI: 884838088108; Serial Numbers: 11044, 11009, 11029, 11043, 11040, 11039, 11090;

   Quantity

   82

   Classification

   Class II

10. MR 5300 Model Number (REF): 1. 782110, 2. 782152;

    FDA recall number

    Z-3241-2026

    Codes, lots and dates

    1. Model Number (REF): 782110; UDI-DI: 884838099364; Serial Numbers: 63383, 63384, 63385, 63386, 63422, 63435, 63643, 63346, 63021, 63054, 63091, 63092, 63113, 63313, 63314, 63315, 63322, 63521, 63524, 63565, 63572, 63593, 63604, 63639, 63694, 63697, 63705, 63706, 63707, 63716, 63721, 63727, 63736, 63737, 63739, 63743, 63750, 63753, 63754, 63755, 63769, 63773, 63617, 63560, 63038, 63484, 63023, 63064, 63066, 63075, 63086, 63149, 63161, 63183, 63194, 63195, 63198, 63199, 63308, 63319, 63331, 63334, 63336, 63364, 63371, 63412, 63425, 63429, 63430, 63452, 63515, 63525, 63609, 63615, 63633, 63636, 63638, 63666, 63668, 63675, 63687, 63689, 63690, 63695, 63696, 63729, 63730, 63742, 63763, 63765, 63774, 63787, 63806, 63829, 63686, 63193, 63257, 63431, 63583, 63592, 63123, 63155, 63474, 63576, 63416, 63748, 63337, 63456, 63046, 63157, 63357, 63569, 63000, 63325, 63504, 63506, 63104, 63110, 63115, 63186, 63248, 63250, 63252, 63343, 63344, 63586, 63785, 63820, 63821, 63328, 63664, 63771, 63457, 63070, 63356, 63011, 63013, 63022, 63028, 63083, 63095, 63107, 63202, 63292, 63365, 63432, 63490, 63499, 63500, 63594, 63031, 63217, 63219, 63220, 63221, 63271, 63309, 63025, 63125, 63211, 63451, 63508, 63541, 63559, 63623, 63745, 63019, 63034, 63058, 63084, 63168, 63218, 63374, 63443, 63510, 63057, 63063, 63493, 63513, 63564, 63612, 63684, 63719, 63812, 63366, 63372, 63026, 63074, 63093, 63099, 63109, 63111, 63112, 63130, 63169, 63175, 63176, 63177, 63178, 63188, 63210, 63223, 63224, 63228, 63229, 63240, 63312, 63333, 63341, 63342, 63389, 63408, 63413, 63428, 63466, 63483, 63487, 63523, 63531, 63532, 63533, 63557, 63566, 63567, 63571, 63596, 63598, 63602, 63614, 63618, 63619, 63632, 63650, 63665, 63672, 63673, 63677, 63732, 63749, 63035, 63041, 63043, 63047, 63062, 63090, 63100, 63128, 63136, 63140, 63141, 63150, 63152, 63160, 63162, 63172, 63173, 63182, 63222, 63238, 63244, 63253, 63258, 63363, 63367, 63370, 63393, 63394, 63126, 63323, 63558, 63080, 63699, 63514, 63388, 63410, 63411, 63723, 63311, 63375, 63507, 63159, 63396, 63122, 63068, 63433, 63001, 63784, 63679, 63409, 63756, 63762, 63434, 63259, 63379, 63277, 63301, 63187, 63464, 63758, 63759, 63098, 63134, 63326, 63355, 63418, 63561, 63562, 63624, 63032, 63036, 63069, 63139, 63437, 63438, 63439, 63610, 63700, 63708, 63709, 63710, 63733, 63738, 63746, 63786, 63103, 63164, 63534, 63563, 63589, 63631, 63127, 63603, 63720, 63482, 63489, 63494, 63498, 63547, 63555, 63106, 63108, 63402, 63475, 63698, 63775, 63776, 63822, 63825, 63273, 63424, 63626, 63397, 63398, 63445, 63006, 63008, 63009, 63015, 63016, 63024, 63030, 63042, 63044, 63049, 63053, 63105, 63135, 63138, 63151, 63153, 63154, 63492, 63352, 63059, 63497, 63681, 63488, 63503, 63722, 63071, 63072, 63294, 63295, 63296, 63297, 63299, 63340, 63361, 63455, 63519, 63724, 63770, 63067, 63174, 63191, 63197, 63449, 63674, 63800, 63798, 63039, 63165, 63318, 63330, 63380, 63440, 63012, 63014, 63018, 63029, 63033, 63087, 63196, 63203, 63204, 63316, 63520, 63587, 63477, 63530, 63740, 63201, 63400, 63401, 63446, 63453, 63478, 63502, 63550, 63597, 63605, 63616, 63704, 63747, 63757, 63780, 63823, 63824, 63833, 63119, 63442, 63461, 63570, 63766, 63767, 63810; 2. Model Number (REF): 782152; UDI-DI: N/A; Serial Numbers: 69304, 69349, 69098, 69101, 69250, 69318, 69321, 69338, 69238, 69239, 69024, 69026, 69034, 69039, 69046, 69081, 69083, 69105, 69151, 69235, 69023, 69037, 69041, 69066, 69112, 69152, 69233, 69302, 69299, 69193, 69194, 69241, 69287, 69320, 69070, 69071, 69106, 69110, 69127, 69161, 69360, 69366, 69044, 69045, 69048, 69116, 69286, 69300, 69351, 69055, 69073, 69075, 69086, 69191, 69207, 69243, 69252, 69258, 69260, 69261, 69262, 69264, 69268, 69270, 69288, 69290, 69295, 69296, 69297, 69000, 69003, 69008, 69010, 69011, 69014, 69015, 69017, 69030, 69147, 69312, 69325, 69326, 69327, 69328, 69329, 69330, 69331, 69332, 69333, 69334, 69289, 69340, 69115, 69200, 69201, 69263, 69154, 69342, 69348, 69170, 69135, 69139, 69197, 69271, 69277, 69133, 69185, 69215, 69234, 69038, 69189, 69053, 69058, 69065, 69078, 69085, 69092, 69103, 69122, 69123, 69169, 69177, 69179, 69216, 69220, 69221, 69224, 69225, 69228, 69229, 69267, 69301, 69305, 69306, 69307, 69313, 69314, 69323, 69343, 69365, 69316, 69027, 69096, 69097, 69186, 69212, 69240, 69254, 69255, 69063, 69064, 69069, 69080, 69095, 69126, 69176, 69315, 69005, 69067, 69175, 69198, 69247, 69294, 69298, 69336;

    Quantity

    611

    Classification

    Class II

11. MR 7700 and Upgrade to MR 7700; Model Number (REF): 1. 782120, 2. 782153, 3. 782130 (Upgrade);

    FDA recall number

    Z-3242-2026

    Codes, lots and dates

    1. Model Number (REF): 782120; UDI-DI: 884838104112; Serial Numbers: 65002, 65003, 65014, 65015, 65050, 65029, 65056, 65018, 65021, 65035, 65038, 65000, 65025, 65006, 65008, 65043; 2. Model Number (REF): 782153; UDI-DI: 884838112858; Serial Numbers: 68011, 68022, 68031, 68014, 68012, 68009, 68033, 68053, 68023; 3. Model Number (REF): 782130; UDI-DI: 884838104402; Serial Numbers: 45007, 45052, 45043, 45044, 45552, 71616, 42164, 42066, 42104, 42248, 45263, 71532;

    Quantity

    37

    Classification

    Class II

12. SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T, SmartPath to dStream for XR and 3.0T, SmartPath to Ingenia Elition X; Model Numbers (REF): 1. 781260 (1.5T), 2. 782112 (1.5T), 3. 782146 (1.5T), 4. 782145 (3.0T), 5. 781270 (XR and 3.0T), 6. 782113 (XR and 3.0T), 7. 782129 (XR and 3.0T), 8. 782118 (Ingenia Elition X), 9. 782144 (Ingenia Elition X);

    FDA recall number

    Z-3243-2026

    Codes, lots and dates

    1. Model Number (System): 781260 (1.5T) UDI-DI: 884838095076; Serial Numbers: 32953, 8750, 8554, 9013, 18574, 18801, 18988, 20211, 32923, 32778, 8156, 8752, 10139, 10164, 21379, 21175, 32445, 11100, 18583, 18746, 18761, 18853, 18965, 18986, 20003, 21138, 21349, 21384, 21748, 22144, 22266, 30037, 30139, 30146, 32223, 32458, 33044, 33045, 33220, 33246, 33716, 72250, 5572, 8240, 8734, 8808, 8985, 10183, 12030, 20282, 21466, 32643, 8713, 8917, 10087, 10130, 18673, 18701, 18803, 32283, 22220, 8087, 8215, 8923, 13026, 22127, 32467, 8427, 10528, 8862, 21333, 21710, 21768, 22255, 22256, 22257, 21554, 22070, 32049, 5425, 5447, 5484, 5536, 5539, 5550, 8001, 8084, 8096, 8110, 8175, 8263, 8315, 8318, 8321, 8387, 8401, 8407, 8476, 8486, 8559, 8601, 8611, 8642, 8704, 8804, 8885, 9020, 9024, 10008, 10033, 10061, 10075, 10117, 10170, 10174, 10191, 10717, 11000, 11031, 11062, 11102, 11108, 12121, 18013, 18565, 18631, 18690, 18697, 18894, 18906, 18938, 18957, 20057, 20070, 20160, 21015, 21018, 21020, 21082, 21453, 21814, 21932, 21979, 22194, 30097, 32099, 32134, 32163, 32164, 32176, 32333, 32334, 32340, 32341, 32454, 32636, 32710, 32752, 39018, 39031, 39103, 5499, 5505, 8657, 21296, 32680, 10029, 18987, 8054, 8350, 11064, 11072, 12053, 13011, 18575, 18718, 18720, 18940, 20032, 20055, 20206, 20295, 21004, 21087, 21091, 21141, 21184, 21200, 21210, 21223, 21247, 21261, 21312, 21347, 21451, 21555, 21576, 21582, 21611, 21680, 21691, 21694, 21737, 21739, 21755, 21863, 21878, 21912, 21942, 22017, 22018, 22086, 22093, 22103, 22171, 22240, 30132, 30239, 32140, 32158, 32285, 32441, 32449, 32822, 33023, 33051, 33106, 33126, 33179, 39005, 72081, 8213, 5466, 5537, 5546, 8045, 8311, 8395, 8424, 8431, 8641, 8667, 8712, 8786, 8840, 10102, 10185, 10220, 10457, 10552, 10554, 11017, 11046, 12036, 13001, 18069, 18101, 18509, 18511, 18548, 18655, 18788, 18970, 20111, 20132, 20165, 20196, 20413, 21032, 21362, 21551, 21565, 21623, 21746, 21809, 21890, 21892, 22044, 22055, 22182, 22296, 22299, 30033, 32264, 32316, 32478, 32492, 32506, 32670, 32805, 32849, 32990, 33100, 39037, 72239, 72243, 5511, 8012, 8057, 8060, 8094, 8309, 8481, 8517, 8531, 8561, 8711, 8724, 8843, 8857, 8887, 8896, 8949, 10007, 10151, 10498, 10513, 10719, 10906, 10913, 11005, 11042, 11091, 12055, 12114, 12120, 13029, 13046, 13047, 13062, 13073, 18017, 18107, 18524, 18670, 18704, 18929, 18954, 20002, 20011, 20035, 20187, 20195, 20209, 20237, 20263, 20278, 20288, 20302, 21089, 21129, 21182, 21209, 21213, 21222, 21249, 21278, 21326, 21355, 21403, 21448, 21482, 21519, 21560, 21579, 21583, 21640, 21697, 21759, 21780, 21792, 21969, 21987, 22013, 22031, 22098, 22123, 22157, 22175, 22184, 32132, 32217, 32236, 32258, 39009, 21804, 13069, 33352, 22237, 33062, 8091, 10230, 11022, 12169, 18610, 18800, 18948, 21067, 21481, 32709, 33215, 8639, 8686, 18663, 18699, 21019, 21023, 21359, 32119, 32742, 8086, 8292, 10543, 21591, 22189, 32573, 32145, 21994, 21995, 10086, 10556, 8983, 18985, 8166, 8723, 10161, 10530, 22301, 22342, 32391, 8168, 8451, 21498, 18512, 21929, 22152, 21143, 21612, 22233, 22273, 22285, 8616, 20112, 32311, 32513, 33198, 33366, 10570, 11018, 8354, 8694, 9006, 32200, 5479, 8485, 8550, 8746, 8779, 8799, 9032, 10461, 10716, 12047, 21133, 21294, 21577, 32839, 32845, 11085, 12134, 21438, 22100, 22137, 32094, 32147, 32221, 32296, 32374, 32405, 32059, 32180, 8392, 12115, 20182, 22107, 32359, 32245, 8492, 8895, 10079, 20151, 20152, 20198, 21084, 21454, 21880, 32807, 21880, 5475, 8100, 8352, 8560, 8578, 8630, 8760, 8772, 8835, 8906, 8971, 8975, 9001, 10036, 10196, 10482, 10703, 12033, 12034, 18558, 18726, 20226, 20303, 21108, 21290, 21664, 21665, 21788, 32131, 32174, 33385; 2. Model Number (System): 782112 (1.5T) UDI-DI: 884838098886; Serial Numbers: 18857, 21252, 21684, 30313, 32250, 8266, 8552, 18776, 21771, 21803, 22048, 30058, 30089, 32106, 32400, 32487, 32827, 32897, 33000, 33103, 33189, 33275, 33371, 33404, 33494, 33545, 33547, 33565, 33568, 33749, 33751, 18942, 20224, 21495, 21608, 21726, 22247, 32295, 32673, 32762, 33019, 32724, 30054, 32229, 32265, 32418, 32419, 32558, 32596, 32803, 33033, 33248, 33249, 33470, 33647, 72204, 72208, 22141, 8798, 10169, 10190, 10474, 10521, 12029, 13021, 13024, 18810, 21077, 21090, 21158, 21685, 21740, 22027, 39106, 8298, 18714, 18510, 32469, 21940, 32539, 8573, 10128, 18995, 20099, 20159, 21433, 21893, 22290, 32457, 32577, 32580, 32661, 32719, 32725, 32798, 33082, 75012, 8109, 8876, 10222, 18520, 18651, 18892, 18950, 20171, 21205, 21212, 21298, 21513, 21906, 21939, 22328, 32244, 32348, 32355, 32375, 22051, 22298, 30145, 32412, 32690, 33218, 33635, 33061, 8433, 18707, 30273, 32287, 32624, 33639, 32133, 21164, 32327, 33217, 10028, 21708, 13023, 21127, 21297, 33048, 72275, 32188, 32363, 32364, 32426, 22267, 22173, 32610, 32613, 32799, 32859, 32654, 39070, 21463, 32519, 33338, 10221, 20204, 39021, 22045; 3. Model Number (System): 782146 (1.5T) UDI-DI: 884838108691; Serial Numbers: 32679, 33002, 33480, 33570, 30308, 33611, 32251, 22251, 13013, 21990, 32407, 32683, 8935, 20414, 32116; 4. Model Number (System): 782145 (3.0T) UDI-DI: 884838108684; Serial Numbers: 34256, 38295, 74041, 34144, 17377, 38127, 38313, 73004, 23029, 24062, 34208, 17435, 38276; 5. Model Number (System): 781270 (XR and 3.0T) UDI-DI: 884838095083; Serial Numbers: 17536, 17212, 17508, 24013, 38184, 23011, 17290, 34060, 38366, 17434, 38013, 38109, 17302, 17429, 17006, 17378, 17386, 35073, 38062, 17533, 17590, 34111, 38235, 17204, 17292, 17339, 17415, 17416, 17436, 17447, 23030, 24055, 34032, 34142, 34145, 34152, 34211, 35044, 38037, 38040, 38192, 38202, 38317, 17247, 17265, 17268, 17286, 17353, 17367, 17389, 17425, 17509, 17517, 17572, 17580, 24022, 24036, 34001, 34058, 35020, 35078, 38001, 38020, 38135, 38224, 17524, 23026, 24095, 34083, 34107, 34236, 34249, 35060, 17222, 17242, 17245, 17250, 17299, 17308, 17342, 17357, 17388, 17399, 17493, 17499, 17556, 17559, 17564, 17594, 23034, 24047, 24109, 24110, 24111, 24117, 24134, 34036, 34090, 34096, 34221, 35027, 35046, 35048, 35053, 38005, 38006, 38015, 38032, 38041, 38161, 38168, 17344, 17495, 17570, 17615, 24020, 24133, 34067, 34076, 34292, 38263, 17428, 23036, 38026, 38131, 38134, 17550, 24145, 38217, 38225, 17237, 34250, 38138, 17352, 17274, 34037, 34080, 35047, 38116, 17326, 17172, 17490, 24007, 38126, 17356, 38111, 24107, 38065, 38259, 38300, 38023, 38102, 74011, 17206, 17240, 17284, 17313, 17375, 17459, 17516, 24058, 24076, 34019, 34223, 35019, 35031, 35040; 6. Model Number (System): 782113 (XR and 3.0T) UDI-DI: 884838098909; Serial Numbers: 17449, 17455, 24154, 17470, 34059, 34262, 34056, 24052, 38106, 38066, 38082, 24097, 34172, 38049, 38070, 38142, 17238, 17372, 24135, 34143, 38354, 74036, 35070, 34072, 35041, 38105, 17271, 17346, 24021, 24093, 24146, 34117, 34127, 34128, 34129, 34153, 34202, 35045, 35059, 38094, 38290, 38311, 38310, 17560, 38114, 38166, 38261, 38042, 38281, 34110, 38117, 17521, 38010, 34130, 34304, 38219, 38222, 17307, 38075, 17384, 17461; 7. Model Number (System): 782129 (XR and 3.0T) UDI-DI: 884838105805; Serial Numbers: 34055, 38195; 8. Model Number (System): 782118 (Ingenia Elition X) UDI-DI: 884838099746; Serial Numbers: 71019, 71025, 42072, 42054, 42194, 85676, 42113, 42085, 42049, 42098, 42158, 42159, 85655, 85665; 9. Model Number (System): 782144 (Ingenia Elition X); UDI-DI: 884838108677; Serial Numbers: 71278, 42250, 71508, 71366;

    Quantity

    965

    Classification

    Class II

FDA event ID

99769

Initiated

Voluntary: Firm initiated

Status

Ongoing

Firm location

Cambridge, MA, United States

Date	Recall	Problem	Agency
Oct 7, 2026	Philips recall: Medical Systems Technologies LtdMedical devices · 62	an increased risk of a crash Serious	FDA Class II
Oct 7, 2026	Philips recall: Ingenia Blue Seal SE and Blue Seal XE and 11 more productsMedical devices · 6; 216; 243; 422; 340; 131; 107; 200; 5; 1; 30; 91	When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR… Serious	FDA Class II
Sep 23, 2026	Philips recall: Patient Information Center iX REF:866389 and 1 more productMedical devices · 7359 Units; 312 units	Due to software malfunction, patient information system may freeze and become unresponsive… Serious	FDA Class II
Sep 9, 2026	Philips recall: Brilliance and 3 more productsMedical devices · N/A	Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity… Serious	FDA Class II
Aug 26, 2026	Philips recall: Cardiac Workstation 5000 and 1 more productMedical devices · 796 units; 1,810 units	Device will intermittently provide inaccurate data related to native heart rate. Serious	FDA Class II

All 6 Philips recalls →

Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.