Philips North America recalled three MR imaging systems on December 3, 2025, due to potential stiffness value errors in exported MR Elastography maps. The systems, identified by product code REF: 781270, have software versions R11.1 and R12.1. Users should stop using the devices immediately and contact their healthcare providers for further 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 MR imaging system is used in medical facilities for imaging and diagnostic purposes. Healthcare providers rely on accurate imaging data for patient assessments and treatment plans.
The defect can cause errors in stiffness value readings during MR Elastography, which may lead to incorrect interpretations of patient conditions.
This recall is not part of a broader industry pattern.
Patients may experience delays in diagnosis or treatment due to the recall, prompting healthcare facilities to find alternative solutions in the interim.
Serial numbers can typically be found on the back or underneath the device. Check the manufacturer's label for detailed identification information.
Expect a processing timeline of 4-6 weeks for refunds or replacements.
Keep photos of the recalled device, receipts of the purchase, and any correspondence with Philips North America for your records.
The recall affects MR systems with software versions R11.1 and R12.1. The product code is REF: 781270, with UDI-DI: 00884838095083. The recalled units were distributed worldwide, including 12 states in the U.S. and several countries.
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