Philips North America recalled five Ingenia Elition S MR systems on December 3, 2025. The recall affects systems with software versions R11.1 and R12.1 due to potential errors in stiffness value readings. This issue poses a serious risk to patient safety when interpreting MR Elastography maps.
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 Elition S is a medical imaging system used for non-invasive diagnosis through MR Elastography. Healthcare providers rely on accurate stiffness readings to assess tissue health and diagnose conditions.
Errors in stiffness values can lead to incorrect interpretations of medical images, potentially resulting in misdiagnosis. This can affect patient treatment plans and outcomes.
This recall is not part of a broader industry pattern.
The recall affects healthcare facilities using the Ingenia Elition S systems, which may cause temporary disruptions in patient care until appropriate measures are taken.
Product codes and software versions can typically be found on the device's label or user manual.
Expect a refund or replacement process to take approximately 4-6 weeks.
Keep copies of all communications, receipts, and any correspondence related to the recall for your records.
The recall includes Ingenia Elition S MR systems with product codes REF 781357, REF 782106, and REF 782137. These systems were distributed worldwide, including nationwide in the U.S. states of Arizona, California, Colorado, Illinois, Massachusetts, Maine, Michigan, Minnesota, Mississippi, Nebraska, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Vermont, Washington, and internationally in Belgium, Canada, Denmark, France, Germany, Greece, India, Israel, Japan, Kenya, Netherlands, South Korea, Spain, Sweden, Taiwan, Thailand, and the United Kingdom.
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