FDA · Class II · August 26, 2026

Philips recall: Cardiac Workstation 5000 and 1 more product

Philips North America Llc is recalling Cardiac Workstation 5000 and 1 more product – 796 units; 1,810 units. The U.S. Food and Drug Administration published the recall on August 26, 2026; it began on July 1, 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.

Illustration: An FDA laboratory that tests medical devices – not the recalled product. Photo: U.S. Food and Drug Administration, public domain.

Product	Cardiac Workstation 5000 and 1 more product
Brand	Philips
Company	Philips North America Llc
Type	Medical devices
Classification	Class II
Recall date	July 1, 2026
Published by FDA	August 26, 2026
Quantity	796 units; 1,810 units
Recall ID	99361

As listed by FDA

Recalled products (2)

Cardiac Workstation 5000. Product Number: 860439.
FDA recall number
Z-2955-2026
Codes, lots and dates
Product Number: 860439. UDI: (01)00884838094826. Serial Numbers: US42510185, US42510184, US52510209, US52510200, US52510226, US52510228, US62510247, US62510250, US62510256, US72510286, US82510299, US82510307, US82510300, US82510313, US82510318, US82510314, US82510335, US82510336, US82510341, US82510325, US92510351, US92510353, US92510354, US92510361, US92510362, US92510370, USN2510413, USN2510414, USN2510434, USN2510435, USN2510437, USD2510506, USD2510519, US12610582, USD2510513, US12610598, US22610609, US22610683, US22610691, US22610689, US32610737, US32610744, US32610759, US32610766, US32610749, US32610739, US32610751, USD2510516, USD2510510, USD2510517, USD2510529, USD2510509, US32610752, US32610753, US32610879, US32610880, US32610901, US32610914, US42610946, US32610915, US32610941, US32610932, US42610943, US42610942, US42610959, US42610958, US42610955, US42610974, US42610967, US42610956, US42610993, US42610960, CN72410032, CN92410061, CNO2410064, CNO2410068, CNN2410075, CND2410080, CND2410101, CND2410103, CN12510116, CN12510136, CN22510140, CN22510142, CN22510146, CN32510148, CN32510161, CN42510168, CN42510181, CN42510183, CN52510204, CN52510201, CN52510217, CN62510239, CN62510241, CN62510242, CN62510253, CN62510254, CN62510251, CN72510275, CN72510282, CN72510281, CN72510285, CN72510289, CN72510288, CN72510293, CN72510297, CN82510305, CN82510310, CN82510323, CN82510324, CN82510321, CN92510343, CN92510364, CN92510365, CN92510367, CN92510374, CNO2510380, CNO2510392, CNO2510383, CNO2510386, CNO2510396, CNN2510412, CNN2510410, CNN2510427, CNN2510443, CNN2510444, CNN2510454, CNN2510485, CNN2510486, CND2510503, CND2510502, CND2510508, CND2510528, CND2510530, CND2510566, CND2510575, CND2510574, CN12610585, CN12610590, CN12610595, CN12610593, CN22610612, CN22610681, CN22610707, CN22610735, CN32610755, CN32610760, CN32610761, CN32610762, CN32610763, CN32610765, CN32610818, CN32610826, CN32610910, CN32610913, CN32610912, CN32610924, CN32610923, CN32610929, CN32610930, CN32610933, CN42610944, CN42610951, CN42610970, US42610994
Quantity
796 units
Classification
Class II
Cardiac Workstation 7000. Product Number: 860441.
FDA recall number
Z-2956-2026
Codes, lots and dates
Product Number: 860441. UDI: (01)00884838094833. Serial Numbers: US22520232, US32520244, US32520248, US42520323, US42520320, US42520300, US52520333, US52520332, US52520345, US52520382, US52520359, US52520390, US52520373, US52520412, US52520420, US52520426, US52520461, US62520469, US62520470, US62520474, US62520476, US62520483, US72520504, US72520518, US72520531, US62520499, US72520500, US72520648, US72520526, US72520524, US72520522, US72520517, US72520590, US72520547, US72520592, US82520720, US72520603, US72520640, US72520580, US72520666, US82520755, US82520752, US82520762, US72520662, US72520652, US72520664, US82520771, US82520844, US82520782, US82520774, US82520769, US82520777, US82520775, US82520855, US82520820, US82520823, US82520824, US82520744, US72520678, US82520822, US82520821, US82520726, US72520667, US72520670, US72520668, US82520848, US72520669, US92520885, US82520857, US82520851, US82520863, US92520881, US92520890, US92520901, US92520903, US92520894, US92520905, US92520906, US92520981, USO2521043, USO2521042, USO2521050, USO2521128, USO2521092, USO2521122, USO2521065, USN2521141, US92520990, USN2521132, USN2521144, USN2521149, USN2521130, USN2521179, USN2521150, USN2521161, USN2521163, USN2521164, USN2521160, USO2521072, USN2521175, USN2521170, USN2521176, USN2521185, USN2521206, USN2521211, USN2521214, USN2521213, USN2521196, USN2521226, USN2521223, USN2521249, USN2521215, USN2521224, USN2521246, USN2521243, USN2521235, USN2521221, USN2521222, USN2521342, USN2521198, USN2521254, USN2521252, USN2521294, USN2521286, USN2521258, USN2521257, USN2521256, USN2521307, USN2521288, USN2521287, USD2521394, USN2521289, USN2521300, USN2521296, USD2521365, USN2521302, USD2521427, USD2521407, USD2521436, USD2521433, USD2521448, USD2521440, USD2521475, USD2521430, USN2521308, USD2521362, USD2521374, USN2521309, USD2521355, US12621548, US12621550, US12621553, US12621671, US12621672, US12621629, US12621713, US12621712, US12621711, US12621710, US22621762, US22621763, US22621777, US22621787, US22621796, US22621859, US32621881, US32621887, US32621893, US32621905, US32621886, US32621884, US32621894, US32621906, US32621907, US32621909, US32621910, USD2521420, USD2521409, USD2521411, USD2521416, USD2521422, US32621911, US32621918, US32621912, US32621913, US32621936, US32622017, US32621923, US32621980, US32621953, US32621952, US32621950, US32621954, US32621895, US32622011, US32622018, US32622051, US32622023, US32622077, US32622078, US32622046, US42622153, US32622027, US32622053, US32622052, US32622076, US32622064, US42622108, US32622065, US42622129, US42622123, US42622110, US42622148, US42622113, US42622111, US42622154, US42622147, US42622139, US42622146, US42622116, US42622149, US42622150, US42622222, US42622188, US42622183, US42622187, US42622156, US42622184, CN72420050, CN82420071, CNO2420085, CNN2420093, CNN2420096, CNN2420111, CNN2420115, CND2420119, CND2420145, CND2420134, CND2420150, CND2420151, CND2420168, CND2420167, CND2420169, CND2420171, CN12520174, CN22520206, CN22520215, CN22520218, CN22520214, CN22520226, CN22520242, CN32520246, CN42520274, CN42520317, CN42520291, CN52520389, CN52520379, CN52520445, CN52520460, CN52520454, CN62520466, CN62520487, CN72520565, CN72520650, CN72520631, CN82520721, CN72520651, CN82520758, CN82520764, CN82520791, CN82520792, CN82520793, CN82520837, CN82520842, CN82520864, CN82520809, CN92520880, CN92520871, CN92520923, CN92520929, CN92520970, CN92520935, CN92520979, CN92520976, CNO2521015, CNO2520997, CNO2521008, CNO2521007, CNO2521026, CNO2521030, CNO2520998, CNN2521156, CNN2521212, USN2521219, CNN2521230, CNN2521283, CNN2521260, USN2521291, CNN2521346, CNN2521345, CNN2521344, CNN2521343, CND2521375, CND2521352, CND2521415, CND2521439, USD2521429, CND2521506, CN12621557, CND2521535, CND2521544, CN12621562, CN12621580, CN12621577, CN12621576, CN12621579, CN12621690, CN12621687, CN12621696, CN12621697, CN12621698, CN22621734, CN22621799, CN22621798, CN32621877, CN22621874, CN32621875, CN32621888, CN32621890, CN32621896, CN32621968, CN32621997, CN32622002, CN32621990, CN32621983, CN32622007, CN32622008, CN32622005, CN32622006, CN32622021, CN32622047, CN32622066, CN32622075, CN42622107, CN42622124, CN42622134, CN42622220, CN42622221
Quantity
1,810 units
Classification
Class II

Exactly as the agency lists them

Identifiers and details

FDA event ID: 99361
Initiated: Voluntary: Firm initiated
Status: Ongoing
Firm location: Cambridge, MA, United States

Why it was recalled

The reason the FDA lists: “Device will intermittently provide inaccurate data related to native heart rate.”

Where it was sold

Nationwide. Distribution as the FDA records it: “Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Belgium, Brazil, Canada, Croatia, Czech Republic, Dominican Republic, France, Germany, Gibraltar, Hong Kong, Iceland, Ireland, Iraq, Italy, Luxembourg, Malta, Netherlands, New Caledonia, New Zealand, Norway, Poland, Portugal, Qatar, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom.”

What to do

Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.

Official notice: FDA Enforcement Report record (event 99361, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.

Same brand

Other Philips recalls

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 30, 2026	Philips recall: Achieva 1.5T and 11 more productsMedical devices · 387; 210; 15; 91; 2038; 922; 1447; 596; 82; 611; 37; 965	A software issue will terminate an examination during the image reconstruction process if … 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

All 6 Philips recalls →

FAQ

About this recall

Is Philips Cardiac Workstation 5000 recalled?

Yes. Philips North America Llc recalled it on July 1, 2026; FDA published it August 26, 2026 (Class II). Only the lots, dates or models listed on this page are included.

Why was it recalled?

Device will intermittently provide inaccurate data related to native heart rate.

What should I do if I have it?

Where was it sold?

Nationwide.

Recalls

More 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.