Philips North America recalled one unit of its Evolution Upgrade 3.0T on December 3, 2025, due to potential stiffness value errors in MR Elastography stiffness maps. The issue affects software versions R11.1 and R12.1. Affected units may misrepresent medical imaging data, posing risks to patient diagnoses.
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 involves the Evolution Upgrade 3.0T, Product Code (REF): 782143, specifically MR systems with software versions R11.1 and R12.1. The unit has a Unique Device Identifier (UDI-DI) of 00884838108660. The system has been distributed across the United States and internationally.
The recall concerns stiffness value errors when viewing exported MR Elastography stiffness maps on Picture Archiving and Communication Systems (PACS). This error can lead to incorrect patient assessments, impacting diagnosis and treatment.
There are no reported incidents or injuries related to this recall at this time. Patients and providers are advised to stop using the device to prevent misdiagnosis.
Stop using the MR system immediately. Follow the recall instructions provided by Philips North America. Contact your healthcare provider or Philips for further guidance.
For assistance, call Philips North America. Detailed information can be found at their official website or the FDA recall page.
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