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): 781356, UDI-DI: 00884838090040, Serial Numbers: 47206, 47038, 47068, 47260, 47294, 47029 +12 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
About This Product
The Ingenia Ambition X MR systems are advanced medical imaging devices used for non-invasive diagnostic procedures. They are typically employed in hospitals and clinics for evaluating tissue properties through MR Elastography.
Why This Is Dangerous
The recall highlights potential errors in stiffness values when viewing MR Elastography maps, which can result in incorrect medical interpretations. This risk necessitates immediate cessation of device use until resolution.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall impacts healthcare providers and patients, as it requires immediate action to prevent potential misdiagnoses and ensures the accuracy of medical imaging.
Practical Guidance
How to identify if yours is affected
- Check if your device is one of the recalled models with software versions R11.1 and R12.1.
- Locate the product codes REF 781356, 782109, or 782138 on your device.
- Verify the serial numbers listed in the recall notification.
Where to find product info
Serial numbers can be found on the device label, typically located on the back or side of the unit.
What timeline to expect
Expect a timeline of 4-6 weeks for the processing of any refunds or replacements once initiated.
If the manufacturer is unresponsive
- Document all communications with Philips North America.
- Follow up with a phone call if you do not receive a response within a reasonable time frame.
- Consider contacting relevant health authorities if issues persist.
How to prevent similar issues
- Inquire about the latest software updates before purchasing MR systems.
- Check for recent recalls or safety alerts for similar medical devices.
Documentation advice
Keep all correspondence regarding the recall, including the notification letter, emails, and notes from phone calls.
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Product Details
The recalled Ingenia Ambition X MR systems include product codes REF 781356, 782109, and 782138 with software versions R11.1 and R12.1. They were sold in the U.S. states of AZ, CA, CO, IL, MA, ME, MI, MN, MS, NE, NY, OH, OR, PA, SC, TN, TX, VA, VT, WA and in multiple countries including Canada, Germany, and the United Kingdom.
Key Facts
- Recall affects 21 units of Ingenia Ambition X MR systems
- Software versions R11.1 and R12.1
- Distributed in multiple U.S. states and countries
- Healthcare providers must stop using devices
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Safety Guide
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