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 Systems
- Model numbers
- MR systems with SW version R11.1 and R12.1. (1) Product Code (REF): 782120, UDI-DI: 00884838104112, Serial Numbers: 65019, 65060, 65066, 65065, 65051, 65038 +4 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 stiffness value errors can lead to incorrect stiffness measurements in MR Elastography, potentially resulting in misdiagnosis or inappropriate treatment plans for patients.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall impacts healthcare providers and patients relying on accurate imaging for diagnosis. Misinterpretation of stiffness values may lead to incorrect treatment decisions, highlighting the urgency for immediate action.
Practical Guidance
How to identify if yours is affected
- Check the software version of your MR system.
- Verify the product code and serial numbers against the recall notice.
- Contact your healthcare provider for confirmation if unsure.
Where to find product info
You can find the product code and serial numbers on the device's label or user manual.
What timeline to expect
Expect a timeline of 4-6 weeks for refund processing after submitting your recall request.
If the manufacturer is unresponsive
- Document all communication attempts with Philips North America.
- Consider following up via phone or email to escalate your request.
How to prevent similar issues
- When purchasing medical devices, ensure they have the latest software updates.
- Verify the manufacturer's reputation for quality and safety.
- Consult with healthcare providers about device reliability before purchasing.
Documentation advice
Keep a copy of the recall notice, all correspondence with the manufacturer, and any receipts or purchase records.
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Product Details
The recall involves 9 units of MR 7700 systems with software versions R11.1 and R12.1. Affected product codes include REF 782120 and REF 782153. These devices were distributed worldwide, including in states such as California, New York, and Texas.
Key Facts
- Recalled product: MR 7700 systems
- Class II recall due to software errors
- Stop using devices immediately
- Contact healthcare provider for instructions
- Worldwide distribution including the US
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Safety Guide
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