CanadaPhilips Achieva 3.0T MRI System — Main Unit (model ACHIEVA 3.0T) from Philips Medical Systems Nederland is affected, specifically systems running software versions R11.1 to R12.1. Philips identified potential stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps in a viewer Picture Archiving and Communication System (PACS), which could pose a risk to patients. Contact the manufacturer for additional information.
What's being recalled
Companies: Philips Medical Systems Nederland B.V., Veenpluis 6, Best, Netherlands, 5684 PC.
How to identify it
Affected products: Achieva 3.0T MRI System-Main Unit; Lot or serial number: Not applicable.; Model or catalogue number: ACHIEVA 3.0T
The hazard
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).
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)