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): 782148. UDI-DI: 00884838108714. Serial Numbers: 70769, 70983. (2) Product Code (REF): 782116. UDI-DI: 00884838099722. Serial Number: 84741.
- 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 defect in the software can cause stiffness value errors in MR Elastography, compromising image quality and potentially leading to incorrect medical evaluations.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall affects the reliability of medical imaging, which is crucial for patient diagnosis and treatment. Healthcare facilities must address this issue immediately to ensure patient safety.
Practical Guidance
How to identify if yours is affected
- Check the product code on the device for REF 782148 or REF 782116.
- Confirm the software version is R11.1 or R12.1.
- Review correspondence from Philips North America regarding the recall.
Where to find product info
The product codes and software versions are typically found on the device label or in the system settings menu.
What timeline to expect
Expect a response regarding the recall and potential refunds or replacements within 4-6 weeks.
If the manufacturer is unresponsive
- Document all attempts to contact Philips North America.
- Consider reaching out to the FDA if the company is unresponsive.
How to prevent similar issues
- Always verify product recalls through official channels like the FDA.
- Stay informed about updates on medical device safety.
- Consider alternative brands or models with a proven safety record.
Documentation advice
Keep all correspondence regarding the recall, as well as any receipts or documentation of the device's purchase.
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Product Details
The recall involves MR systems with software versions R11.1 and R12.1, specifically product codes REF 782148 and REF 782116. Three units are affected, distributed across multiple states in the U.S. and countries including Canada, Germany, and the United Kingdom.
Key Facts
- Affected models include REF 782148 and REF 782116.
- Software versions R11.1 and R12.1 are involved.
- Three units recalled worldwide.
- Healthcare providers must cease use immediately.
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Safety Guide
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