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. Product Code (REF): 782143. UDI-DI: 00884838108660. Serial Numbers: 42225.
- 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 Evolution Upgrade 3.0T is a medical device used in MRI systems to assess tissue stiffness. Healthcare providers utilize this data for diagnostic purposes, particularly in conditions like liver disease.
Why This Is Dangerous
The stiffness value errors can lead to incorrect interpretations of MR Elastography data, potentially resulting in misdiagnosis or inappropriate treatment decisions.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall affects the accuracy of medical imaging, which may delay patient diagnosis and treatment.
Practical Guidance
How to identify if yours is affected
- Check the software version of the MR system.
- Verify if the product code matches REF: 782143.
- Look for the Unique Device Identifier (UDI-DI) on the device.
Where to find product info
The UDI can typically be found on the device label or in the user manual.
What timeline to expect
Expect a processing time of 4-6 weeks for any refund or replacement requests.
If the manufacturer is unresponsive
- Contact Philips customer service directly.
- Document all correspondence regarding the recall.
- Consider reporting the issue to the FDA if no response is received.
How to prevent similar issues
- Stay updated on manufacturer recalls and safety notices.
- Ensure compliance with industry safety standards when using medical devices.
Documentation advice
Keep all receipts, correspondence with Philips, and records of device identification for reference.
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Product Details
The recall involves the Evolution Upgrade 3.0T, Product Code (REF): 782143, specifically MR systems with software versions R11.1 and R12.1. The unit has a Unique Device Identifier (UDI-DI) of 00884838108660. The system has been distributed across the United States and internationally.
Key Facts
- Recall date: December 3, 2025
- Classification: Class II
- Quantity recalled: 1 unit
- Affected states include AZ, CA, CO, IL, MA, ME, MI, MN, MS, NE, NY, OH, OR, PA, SC, TN, TX, VA, VT,
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Safety Guide
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