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 Evolution Upgrade 3.0T is a medical device used in MRI systems to assess tissue stiffness. Healthcare providers utilize this data for diagnostic purposes, particularly in conditions like liver disease.
The stiffness value errors can lead to incorrect interpretations of MR Elastography data, potentially resulting in misdiagnosis or inappropriate treatment decisions.
This recall is not part of a broader industry pattern.
The recall affects the accuracy of medical imaging, which may delay patient diagnosis and treatment.
The UDI can typically be found on the device label or in the user manual.
Expect a processing time of 4-6 weeks for any refund or replacement requests.
Keep all receipts, correspondence with Philips, and records of device identification for reference.
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.
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