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 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.
The recall addresses potential stiffness value errors when viewing MR Elastography stiffness maps on Picture Archiving and Communication System (PACS). These errors could lead to incorrect medical interpretations.
No specific incidents or injuries have been reported concerning this recall. The recall is classified as Class II, indicating a potential risk that may cause temporary health issues.
Stop using the Ingenia Ambition S MR systems immediately. Contact Philips North America or your healthcare provider for detailed instructions on handling the recall.
For assistance, patients and healthcare providers can contact Philips North America directly. Visit the FDA website for more details.
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