CanadaPhilips Medical Systems Nederland B.V. has identified affected MRI systems: Ingenia 1.5T (serial 70851), Ingenia Elition X (serials 45052, 45590, 62158), Ingenia Ambition X (serial 49004), and Achieva 3.0T MRI systems (serials 17385, 38109). The reconstruction voxel size settings in the default MRE scan protocol can be too small when used with Resoundant’s algorithm, which can potentially lead to inaccurate (lower) liver stiffness measurements. Contact the manufacturer if you require 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: Ingenia 1.5T; Lot or serial number: 70851; Model or catalogue number: 1.5T
Affected products: Ingenia Elition X; Lot or serial number: 45052; Model or catalogue number: 781358
Affected products: Ingenia Elition X; Lot or serial number: 45590; Model or catalogue number: 782107
Affected products: Ingenia Elition X; Lot or serial number: 62158; Model or catalogue number: 782107
Affected products: Ingenia Ambition X; Lot or serial number: 49004; Model or catalogue number: 782138
Affected products: Achieva 3.0T MRI System - Main Unit; Lot or serial number: 17385; Model or catalogue number: ACHIEVA 3.0T
Affected products: Achieva 3.0T MRI System - Main Unit; Lot or serial number: 38109; Model or catalogue number: ACHIEVA 3.0T
The hazard
Philips has become aware through the MRE software system developer Resoundant about an issue affecting MRE stiffness measurements when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm. Specifically, the reconstruction voxel size settings in the default MRE scan protocol are too small, which can potentially lead to inaccurate liver stiffness measurements (lower values).
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)