Quick Facts at a Glance
- Recall Date
- December 3, 2025
- Hazard Level
- HIGH
- Brand
- Philips North America
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Philips North America
- Product type
- MR System
- Model numbers
- MR systems with SW version R11.1 and R12.1. (1) Product Code (REF): 781342, UDI-DI: 00884838055339, Serial Numbers: 71607, 85216, 71087, 71619, 71462, 71002 +12 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 3, 2025
Reported by FDA DEVICE
February 4, 2026
RecallRadar source check
February 11, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Philips North America or your healthcare provider for instructions. Notification method: Letter
Why This Is Dangerous
The recall addresses potential errors in stiffness value readings from MR Elastography maps, which can lead to incorrect assessments of tissue conditions. This risk underlines the importance of accurate imaging in medical diagnostics.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall may result in temporary disruptions in diagnostic services for healthcare providers using the affected MR systems. This could impact patient care and necessitate alternative imaging solutions in the interim.
Practical Guidance
How to identify if yours is affected
- Check the product code of your Ingenia 3.0T MR system.
- Verify the software version is R11.1 or R12.1.
- Refer to the serial numbers listed in the recall notice.
Where to find product info
Product codes and serial numbers can usually be found on the device's information label or in the device's user manual.
What timeline to expect
Expect a timeline of approximately 4 to 6 weeks for refund processing after following the recall instructions.
If the manufacturer is unresponsive
- Follow up with Philips North America using their contact information.
- Document all correspondence regarding the recall.
How to prevent similar issues
- Check for FDA recalls before purchasing medical devices.
- Ensure proper training for staff on the use of MR systems and awareness of potential recalls.
- Stay informed on updates from manufacturers regarding device performance.
Documentation advice
Keep records of your MR system's product code, serial number, and any correspondence related to the recall for future reference.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
The recalled products are Ingenia 3.0T MR systems with product codes 781342 and 781377. They were sold in the United States and internationally in countries including Canada, France, and Germany. The recall involves 24 units.
Key Facts
- Software versions: R11.1, R12.1
- Recall date: December 3, 2025
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.