Health Canada — Medical Devices · Canada · 2025-12-18 · Type II
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Reported risk: Philips has become aware through in-house testing of a potential safety issue affecting MR systems operating on software versions R11.1 to R12.1 that could pose a risk for patients. Philips has identified potential stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
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