HIGH

Philips Ingenia 1.5T MR Systems Recalled Over Stiffness Value Errors

Philips North America recalled 10 Ingenia 1.5T MR systems on December 3, 2025, due to potential stiffness value errors. The affected models include Product Codes 781341 and 781396 with software versions R11.1 and R12.1. Healthcare providers must stop using these devices immediately to prevent misdiagnosis.

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

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

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About This Product

The Ingenia 1.5T MR system is used for medical imaging, particularly MR Elastography, to evaluate tissue stiffness. Healthcare providers use this equipment to diagnose various conditions based on stiffness measurements.

Why This Is Dangerous

The defect can lead to stiffness value errors in imaging results, which may mislead healthcare providers and affect patient diagnoses. This could potentially compromise patient safety if misinterpretations occur.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

The recall can disrupt imaging services and requires immediate action by healthcare providers, potentially delaying patient diagnoses.

Practical Guidance

How to identify if yours is affected

  1. Check the product code against the recall notice.
  2. Verify the software version is R11.1 or R12.1.
  3. Look for serial numbers listed in the recall documentation.

Where to find product info

Serial numbers can typically be found on the device's identification plate or in the device's user manual.

What timeline to expect

Expect 4-8 weeks for refund or replacement processing after submission of recall instructions.

If the manufacturer is unresponsive

  • Document all correspondence with Philips North America.
  • Consider reaching out to regulatory bodies if there is no follow-up.

How to prevent similar issues

  • Always verify the latest product recalls before using medical devices.
  • Consult regulatory websites for updates on medical equipment safety.
  • Ensure regular maintenance checks are performed on medical devices.

Documentation advice

Keep a record of all communications, receipts, and any relevant documents regarding the recall.

Product Details

The recall affects Ingenia 1.5T MR systems with Product Codes (REF): 781341 and 781396. These systems were distributed worldwide, including multiple U.S. states and countries such as Canada and Germany. The systems were sold as part of standard medical imaging equipment.

Key Facts

  • Recall date: December 3, 2025
  • 10 units recalled
  • Affected models: Product Code 781341, 781396
  • Software Versions: R11.1, R12.1

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
MR systems with SW version R11.1 and R12.1. (1) Product Code (REF): 781341
UDI-DI: 00884838055322
Serial Numbers: 70311
84560
84403
+8 more
Affected States
ALL
Report Date
February 4, 2026
Recall Status
ACTIVE

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