HIGH

Philips Recalled Ingenia Ambition X MR Systems Over Stiffness Errors

Philips North America recalled 21 Ingenia Ambition X MR systems on December 3, 2025, due to potential stiffness value errors. The recall affects models with software versions R11.1 and R12.1, distributed in the U.S. and worldwide. Healthcare providers must stop using these devices immediately and follow provided instructions.

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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Product Details

The recalled Ingenia Ambition X MR systems include product codes REF 781356, 782109, and 782138 with software versions R11.1 and R12.1. They were sold in the U.S. states of AZ, CA, CO, IL, MA, ME, MI, MN, MS, NE, NY, OH, OR, PA, SC, TN, TX, VA, VT, WA and in multiple countries including Canada, Germany, and the United Kingdom.

The Hazard

The recall stems from potential errors in stiffness values when viewing exported MR Elastography stiffness maps on Picture Archiving and Communication Systems (PACS). This issue could lead to incorrect assessments in medical imaging.

What to Do

Healthcare providers should stop using the affected devices immediately. They should follow the recall instructions provided in the notification letter and contact Philips North America for further guidance.

Contact Information

For assistance, call Philips North America at 1-800-xxx-xxxx or visit their website for further instructions.

Key Facts

  • Recall affects 21 units of Ingenia Ambition X MR systems
  • Software versions R11.1 and R12.1
  • Distributed in multiple U.S. states and countries
  • Healthcare providers must stop using devices

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 Details

Model Numbers
MR systems with SW version R11.1 and R12.1. (1) Product Code (REF): 781356
UDI-DI: 00884838090040
Serial Numbers: 47206
47038
47068
+15 more
Affected States
ALL
Report Date
February 4, 2026
Recall Status
ACTIVE

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