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 Imaging System
- Model numbers
- MR systems with SW version R11.1 and R12.1. Product Code (REF): 781270. UDI-DI: 00884838095083. Serial Numbers: 24066, 38113, 17356.
- 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 MR imaging system is used in medical facilities for imaging and diagnostic purposes. Healthcare providers rely on accurate imaging data for patient assessments and treatment plans.
Why This Is Dangerous
The defect can cause errors in stiffness value readings during MR Elastography, which may lead to incorrect interpretations of patient conditions.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients may experience delays in diagnosis or treatment due to the recall, prompting healthcare facilities to find alternative solutions in the interim.
Practical Guidance
How to identify if yours is affected
- Check the product code for REF: 781270.
- Verify the software version is R11.1 or R12.1.
- Locate the serial number on the device to confirm it's affected.
Where to find product info
Serial numbers can typically be found on the back or underneath the device. Check the manufacturer's label for detailed identification information.
What timeline to expect
Expect a processing timeline of 4-6 weeks for refunds or replacements.
If the manufacturer is unresponsive
- Document your communication attempts with Philips North America.
- Contact consumer protection agencies for assistance if necessary.
- Consider reaching out to regulatory bodies for further support.
How to prevent similar issues
- Ensure any future medical devices have updated software and safety certifications.
- Research the manufacturer's history regarding recalls before purchase.
- Check for user reviews to assess reliability and safety of medical devices.
Documentation advice
Keep photos of the recalled device, receipts of the purchase, and any correspondence with Philips North America for your records.
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Product Details
The recall affects MR systems with software versions R11.1 and R12.1. The product code is REF: 781270, with UDI-DI: 00884838095083. The recalled units were distributed worldwide, including 12 states in the U.S. and several countries.
Key Facts
- Recall date: December 3, 2025
- Affected software versions: R11.1 and R12.1
- Product code: REF: 781270
- Quantity recalled: 3 units
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