Philips North America recalled 6 MR systems on December 3, 2025, due to the potential for stiffness value errors. These errors can occur when viewing exported MR Elastography stiffness maps on Picture Archiving and Communication Systems. Users should stop using the devices 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 recall affects MR systems with software versions R11.1 and R12.1 and product code REF 782130. These devices were distributed worldwide, including states like Arizona, California, and New York, as well as countries such as Canada, Germany, and Japan.
The recalled MR systems may produce stiffness value errors when generating MR Elastography stiffness maps. Such inaccuracies can lead to misinterpretation of patient conditions.
As of now, no specific incidents or injuries have been reported related to this recall. However, the potential for misdiagnosis due to stiffness value errors presents a significant risk.
Stop using the recalled MR systems immediately. Contact Philips North America or your healthcare provider for further instructions on how to proceed. Follow the recall instructions provided in the notification letter.
For more information, contact Philips North America through their website or call their customer service.
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