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. Product Code (REF): 782108. UDI-DI: 00884838098343. Serial Numbers: 48669.
- 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 hazard involves potential errors in stiffness value interpretation when viewing MR elastography maps. Incorrect stiffness assessments could lead to misdiagnosis or inappropriate treatment plans.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall may cause inconvenience to healthcare providers and patients relying on accurate imaging for diagnosis. Users must stop using the device immediately, which could delay medical evaluations.
Practical Guidance
How to identify if yours is affected
- Check the product code to see if it is REF 782108.
- Verify the software version; affected versions are R11.1 and R12.1.
- Look for any notification letters from Philips regarding the recall.
Where to find product info
Product codes and software versions can typically be found on the device label or in the user manual.
What timeline to expect
Expect a refund or replacement to process within 4-8 weeks after following the recall instructions.
If the manufacturer is unresponsive
- Document all communication attempts with Philips.
- Reach out to your healthcare provider for assistance.
- Consider filing a complaint with the relevant health authorities.
How to prevent similar issues
- Research the safety ratings and recall history of medical devices before purchase.
- Only buy from reputable manufacturers with good customer service records.
- Stay informed about product recalls and safety alerts through health channels.
Documentation advice
Keep a record of all correspondence related to the recall, including letters or emails from Philips.
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Product Details
The recalled product is the Ingenia Ambition S MR system, Product Code REF: 782108, with software versions R11.1 and R12.1. It was distributed worldwide, including states like California, Texas, and New York, as well as countries such as Belgium and Japan.
Key Facts
- Recalled product: Ingenia Ambition S MR system
- Product Code: REF 782108
- Software versions R11.1 and R12.1
- Distributed in multiple U.S. states and worldwide
- Class II recall, potentially high hazard
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Safety Guide
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