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
- MRI System
- Model numbers
- MR systems with SW version R11.1 and R12.1. (1) Product Code (REF): 781358, UDI-DI: 00884838088115, Serial Numbers: 45414, 45245, 45090, 45049, 45034, 45250 +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 Elition X MRI system is used for medical imaging to provide detailed images of the body. Healthcare providers rely on accurate readings from these systems for diagnosis and treatment planning.
Why This Is Dangerous
The recall addresses stiffness value errors in MR Elastography, which can lead to incorrect interpretations of tissue properties. These errors can directly impact patient care and treatment outcomes.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients and healthcare providers must cease use of the affected MRI systems immediately to avoid potential misdiagnosis, which could have serious implications for patient health.
Practical Guidance
How to identify if yours is affected
- Check the product codes: 781358, 782107, 782136.
- Verify the software versions: R11.1 and R12.1.
- Look for serial numbers listed in the recall notice.
Where to find product info
Serial numbers and product codes can typically be found on the device's label or user manual.
What timeline to expect
Expect a response from Philips North America within 4-6 weeks regarding the recall process and any potential refunds.
If the manufacturer is unresponsive
- Document all communication attempts with Philips.
- Reach out to your healthcare provider for assistance.
- File a complaint with the FDA if necessary.
How to prevent similar issues
- Ensure all medical devices have up-to-date software versions.
- Regularly check for recalls on medical devices before use.
- Consult with healthcare providers about device safety.
Documentation advice
Keep records of all communications regarding the recall, including letters from Philips and any correspondence with healthcare providers.
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Product Details
The recall affects 31 units of the Ingenia Elition X MRI systems with software versions R11.1 and R12.1. The specific product codes are 781358, 782107, and 782136. These systems were distributed worldwide, including in 15 US states and multiple countries.
Key Facts
- Recall Date: December 3, 2025
- Reported Date: February 4, 2026
- Quantity Recalled: 31 units
- Hazard: Potential stiffness value errors
- Affected States: AZ, CA, CO, IL, MA, ME, MI, MN, MS, NE, NY, OH, OR, PA, SC, TN, TX, VA, VT, WA
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Safety Guide
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