Philips North America recalled Ingenia Ambition S MR systems on December 3, 2025, due to stiffness value errors in exported MR Elastography maps. The recall affects one unit distributed in multiple U.S. states and several countries. Users must stop using the device immediately and follow recall 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 S MR system is a medical imaging device used for magnetic resonance imaging (MRI). Healthcare providers rely on this technology for accurate diagnostics in various medical conditions.
The hazard involves potential errors in stiffness value interpretation when viewing MR elastography maps. Incorrect stiffness assessments could lead to misdiagnosis or inappropriate treatment plans.
This recall is not part of a broader industry pattern.
The recall may cause inconvenience to healthcare providers and patients relying on accurate imaging for diagnosis. Users must stop using the device immediately, which could delay medical evaluations.
Product codes and software versions can typically be found on the device label or in the user manual.
Expect a refund or replacement to process within 4-8 weeks after following the recall instructions.
Keep a record of all correspondence related to the recall, including letters or emails from Philips.
The recalled product is the Ingenia Ambition S MR system, Product Code REF: 782108, with software versions R11.1 and R12.1. It was distributed worldwide, including states like California, Texas, and New York, as well as countries such as Belgium and Japan.
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