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Health Canada Medical devices

Achieva 3.0T MRI System-Main Unit

Issued December 18, 2025
Issue
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).
Hazard description
Performance
Product
Product name
Achieva 3.0T MRI System-Main Unit
Reference
ID
RA-81380