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 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.
The recall addresses potential stiffness value errors when viewing exported MR Elastography stiffness maps on Picture Archiving and Communication Systems. These inaccuracies could lead to misdiagnosis or inappropriate treatment decisions.
Currently, there are no reported injuries or deaths related to this recall. However, the potential for misinterpretation of medical data poses a high risk to patient safety.
Patients and healthcare providers should stop using the affected MR systems immediately. Contact Philips North America or your healthcare provider for further instructions regarding the recall.
For more information, contact Philips North America at 1-800-XXX-XXXX or visit their website at https://www.philips.com.
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