Philips recall: Patient Information Center iX REF:866389 and 1 more product
Philips North America is recalling Philips Patient Information Center iX REF:866389 and 1 more product – 7359 Units; 312 units. The U.S. Food and Drug Administration published the recall on September 23, 2026; it began on July 31, 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.
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| Product | Philips Patient Information Center iX REF:866389 and 1 more product |
| Brand | Philips |
| Company | Philips North America |
| Type | Medical devices |
| Classification | Class II |
| Recall date | July 31, 2026 |
| Published by FDA | September 23, 2026 |
| Quantity | 7359 Units; 312 units |
| Recall ID | 99566 |
Recalled products (2)
- Philips Patient Information Center iX REF:866389
- FDA recall number
- Z-3141-2026
- Codes, lots and dates
- All PIC iX software versions 4.0-4.5/UDI: (01)00884838127067
- Quantity
- 7359 Units
- Classification
- Class II
- Philips PIC iX Essentials REF:867093
- FDA recall number
- Z-3142-2026
- Codes, lots and dates
- All PIC iX software versions 4.0-4.5/UDI: (01)00884838122772
- Quantity
- 312 units
- Classification
- Class II
Identifiers and details
- FDA event ID
- 99566
- Initiated
- Voluntary: Firm initiated
- Status
- Ongoing
- Firm location
- Cambridge, MA, United States
Why it was recalled
The reason the FDA lists: “Due to software malfunction, patient information system may freeze and become unresponsive.”
Where it was sold
Nationwide. Distribution as the FDA records it: “Worldwide - US Nationwide distribution including in the states and territories of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, PR and the countries of Andorra, Utd. Arab. Emir., Argentina, Austria, Australia, Aruba, Bosnia-Herz., Bangladesh, Belgium, Bulgaria, Bahrain, Bolivia, Brazil, Canada, Switzerland, Chile, Colombia, Costa Rica, Cyprus, Czech Republic, Germany, Denmark, Dominican Rep, Algeria, Estonia, Spain, Finland, Fiji, Faroe Islands, France, United Kingdom, Gibraltar, Guadeloupe, Greece, Hong Kong, Croatia, Hungary, Indonesia, Ireland, Israel, India, Iraq, Iceland, Italy, Jordan, Japan, Kenya, South Korea, Kuwait, Lebanon , Sri Lanka, Lithuania, Luxembourg, Latvia, Libya, Morocco, Monaco, Montenegro, Macedonia, Macao, Martinique, Maldives, Mexico, Malaysia, Namibia, Nicaragua, Netherlands, Norway, New Zealand, Oman, Panama, Peru, Philippines, Pakistan, Poland, Puerto Rico, Portugal, Qatar R¿union, Romania, Serbia, Russian Fed., Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, Thailand, Turkmenistan, Tunisia, T¿rkiye, Taiwan, Ukraine, Uzbekistan, Vietnam, South Africa.”
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 99566, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.
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 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 |
About this recall
Is Philips Philips Patient Information Center iX REF:866389 recalled?
Yes. Philips North America recalled it on July 31, 2026; FDA published it September 23, 2026 (Class II). Only the lots, dates or models listed on this page are included.
Why was it recalled?
Due to software malfunction, patient information system may freeze and become unresponsive.
What should I do if I have it?
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.
Where was it sold?
Nationwide.
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.