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): 781341, UDI-DI: 00884838055322, Serial Numbers: 70311, 84560, 84403, 84467, 84462, 70042 +5 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
About This Product
The Ingenia 1.5T MR system is used for medical imaging, particularly MR Elastography, to evaluate tissue stiffness. Healthcare providers use this equipment to diagnose various conditions based on stiffness measurements.
Why This Is Dangerous
The defect can lead to stiffness value errors in imaging results, which may mislead healthcare providers and affect patient diagnoses. This could potentially compromise patient safety if misinterpretations occur.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall can disrupt imaging services and requires immediate action by healthcare providers, potentially delaying patient diagnoses.
Practical Guidance
How to identify if yours is affected
- Check the product code against the recall notice.
- Verify the software version is R11.1 or R12.1.
- Look for serial numbers listed in the recall documentation.
Where to find product info
Serial numbers can typically be found on the device's identification plate or in the device's user manual.
What timeline to expect
Expect 4-8 weeks for refund or replacement processing after submission of recall instructions.
If the manufacturer is unresponsive
- Document all correspondence with Philips North America.
- Consider reaching out to regulatory bodies if there is no follow-up.
How to prevent similar issues
- Always verify the latest product recalls before using medical devices.
- Consult regulatory websites for updates on medical equipment safety.
Documentation advice
Keep a record of all communications, receipts, and any relevant documents regarding the recall.
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Product Details
The recall affects Ingenia 1.5T MR systems with Product Codes (REF): 781341 and 781396. These systems were distributed worldwide, including multiple U.S. states and countries such as Canada and Germany. The systems were sold as part of standard medical imaging equipment.
Key Facts
- Recall date: December 3, 2025
- Affected models: Product Code 781341, 781396
- Software Versions: R11.1, R12.1
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Safety Guide
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