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): 781357, UDI-DI: 00884838088108, Serial Numbers: 46002. (2) Product Code (REF): 782106, UDI-DI: 00884838098329, Serial Numbers: 46243, 46292. (3) Product Code (REF): 782137, UDI-DI: 00884838108615, Serial Numbers: 64034 +1 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 S is a medical imaging system used for non-invasive diagnosis through MR Elastography. Healthcare providers rely on accurate stiffness readings to assess tissue health and diagnose conditions.
Why This Is Dangerous
Errors in stiffness values can lead to incorrect interpretations of medical images, potentially resulting in misdiagnosis. This can affect patient treatment plans and outcomes.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall affects healthcare facilities using the Ingenia Elition S systems, which may cause temporary disruptions in patient care until appropriate measures are taken.
Practical Guidance
How to identify if yours is affected
- Locate the product code on the system's label.
- Check the software version displayed on the device.
- Verify if your device falls under the recalled models.
Where to find product info
Product codes and software versions can typically be found on the device's label or user manual.
What timeline to expect
Expect a refund or replacement process to take approximately 4-6 weeks.
If the manufacturer is unresponsive
- Document all communications with Philips regarding the recall.
- Follow up with Philips customer service if you do not receive a timely response.
How to prevent similar issues
- When purchasing medical devices, verify the latest software versions and safety certifications.
- Stay informed about product recalls through healthcare networks and regulatory agencies.
Documentation advice
Keep copies of all communications, receipts, and any correspondence related to the recall for your records.
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Product Details
The recall includes Ingenia Elition S MR systems with product codes REF 781357, REF 782106, and REF 782137. These systems were distributed worldwide, including nationwide in the U.S. states of Arizona, California, Colorado, Illinois, Massachusetts, Maine, Michigan, Minnesota, Mississippi, Nebraska, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Vermont, Washington, and internationally in Belgium, Canada, Denmark, France, Germany, Greece, India, Israel, Japan, Kenya, Netherlands, South Korea, Spain, Sweden, Taiwan, Thailand, and the United Kingdom.
Key Facts
- Recall date: December 3, 2025
- Affected software versions: R11.1 and R12.1
- Distribution includes U.S. and multiple countries
- Stop using the device immediately
- Contact Philips for instructions
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Safety Guide
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