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): 781271. UDI-DI: 00884838068452. Serial Numbers: 78017, 78112, 78217, 78123, 78260, 78239.
- 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 3.0T CX MR system is a medical imaging device primarily used for non-invasive diagnostics. Healthcare providers use it to assess various medical conditions through advanced imaging technology.
Why This Is Dangerous
The hazard arises from potential stiffness value errors when exporting MR Elastography stiffness maps to Picture Archiving and Communication Systems. These errors can lead to incorrect diagnoses and treatment decisions.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
This recall may affect healthcare providers' ability to accurately diagnose patients, potentially leading to delays in treatment or incorrect medical interventions.
Practical Guidance
How to identify if yours is affected
- Check the product code and software version against the recall notice.
- Review the serial numbers provided in the recall.
- Contact Philips North America for confirmation if unsure.
Where to find product info
The product code and serial numbers can typically be found on the device's main label or user manual.
What timeline to expect
Expect a timeline of 4-6 weeks for the processing of refunds or replacements.
If the manufacturer is unresponsive
- Contact Philips customer service again for a follow-up.
- Document all interactions and correspondence with the company.
- Consider filing a complaint with the FDA or CPSC if issues persist.
How to prevent similar issues
- Always verify product recalls through official channels before purchasing medical devices.
- Look for recent reviews and alerts about medical devices before use.
- Choose products from reputable manufacturers with good safety records.
Documentation advice
Keep records of all communications with Philips, including emails and receipts related to the purchase of the MR system.
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Product Details
The recalled product is the Ingenia 3.0T CX MR system, Product Code (REF): 781271. The affected software versions are R11.1 and R12.1. The systems were distributed worldwide, including various states in the U.S. and countries such as Canada, Germany, and Japan.
Key Facts
- Recall date: December 3, 2025
- Report date: February 4, 2026
- Quantity recalled: 6 units
- Hazard level: High
- 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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