Philips North America recalled 10 Ingenia 1.5T MR systems on December 3, 2025, due to potential stiffness value errors. The affected models include Product Codes 781341 and 781396 with software versions R11.1 and R12.1. Healthcare providers must stop using these devices immediately to prevent misdiagnosis.
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 affects Ingenia 1.5T MR systems with Product Codes (REF): 781341 and 781396. These systems were distributed worldwide, including multiple U.S. states and countries such as Canada and Germany. The systems were sold as part of standard medical imaging equipment.
The recall addresses the risk of stiffness value errors in exported MR Elastography (MRE) stiffness maps. These errors could lead to incorrect medical interpretations and potentially serious consequences for patient care.
No specific incidents of injury or death have been reported. However, the potential for misdiagnosis raises significant concerns regarding patient safety.
Stop using the affected MR systems immediately. Follow the recall instructions provided by Philips North America and contact your healthcare provider for further instructions.
For more information, contact Philips North America at their official website or through the provided recall instructions.
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