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 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.
The recalled systems may present stiffness value errors when viewing exported MR Elastography stiffness maps on PACS. This error can lead to inaccurate diagnoses and patient management.
There are no reported injuries or incidents associated with this recall. The potential misinterpretation of imaging data poses a serious risk to patient safety.
Stop using the affected MR systems immediately. Follow the recall instructions provided by Philips North America. Contact your healthcare provider for further instructions.
For further assistance, contact Philips North America directly or visit their recall website. You can find details at: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1216-2026.
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