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.
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
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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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 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.
There have been no reported injuries or deaths associated with this recall. The potential for misdiagnosis exists due to the stiffness value errors.
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.
For assistance, call Philips North America at 1-800-xxx-xxxx or visit their website for further instructions.
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