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 Ingenia Ambition X MR systems are advanced medical imaging devices used for non-invasive diagnostic procedures. They are typically employed in hospitals and clinics for evaluating tissue properties through MR Elastography.
The recall highlights potential errors in stiffness values when viewing MR Elastography maps, which can result in incorrect medical interpretations. This risk necessitates immediate cessation of device use until resolution.
This recall is not part of a broader industry pattern.
The recall impacts healthcare providers and patients, as it requires immediate action to prevent potential misdiagnoses and ensures the accuracy of medical imaging.
Serial numbers can be found on the device label, typically located on the back or side of the unit.
Expect a timeline of 4-6 weeks for the processing of any refunds or replacements once initiated.
Keep all correspondence regarding the recall, including the notification letter, emails, and notes from phone calls.
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.
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