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. Product Code (REF): 782130. UDI-DI: 00884838104402. Serial Numbers: 42030, 85644, 42163, 42151, 45236, 85643.
- 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
MR systems are used in medical imaging to assess tissue stiffness, which can help diagnose conditions. Healthcare providers rely on accurate imaging for patient care, making these systems essential in clinical settings.
Why This Is Dangerous
The defect in these MR systems can lead to stiffness value errors, which could mislead healthcare professionals when interpreting patient data. This can result in incorrect diagnoses or treatment plans.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall affects a small number of units but poses significant risks in clinical settings where accurate diagnostic imaging is critical.
Practical Guidance
How to identify if yours is affected
- Verify the software version of your MR system is R11.1 or R12.1.
- Locate the product code REF 782130 on your device.
- Check the serial numbers against the list provided in the recall notice.
Where to find product info
You can find the product code and serial number on the back or underside of the MR system.
What timeline to expect
Expect a refund or replacement processing time of approximately 4-8 weeks.
If the manufacturer is unresponsive
- Document all communication attempts with Philips.
- Contact your healthcare provider for assistance.
- Consider reaching out to the CPSC for further guidance.
How to prevent similar issues
- Always verify product recalls on the manufacturer’s website.
- Look for updated software versions before purchasing medical devices.
- Consult with healthcare professionals about the safety of medical equipment.
Documentation advice
Keep copies of any notifications received, correspondence with the manufacturer, and photographs of the affected device.
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Product Details
The recall affects MR systems with software versions R11.1 and R12.1 and product code REF 782130. These devices were distributed worldwide, including states like Arizona, California, and New York, as well as countries such as Canada, Germany, and Japan.
Key Facts
- Recall date: December 3, 2025
- Affected software versions: R11.1 and R12.1
- Potential for stiffness value errors
- Immediate stop-use advised
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Safety Guide
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