CanadaPhilips Ingenia, Achieva and Intera magnetic resonance (MR) systems running software versions R5 and R11 are affected, including listed models such as Ingenia 1.5T (781315/1.5T), Ingenia 3.0T (781271/3.0T), Ingenia Ambition S/X, Ingenia Elition X, Achieva 1.5T and 3.0T, and Intera 1.5T. Philips identified a software issue that can terminate an examination during image reconstruction and freeze the system if reconstruction requirements exceed available memory. 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: Ingenia 1.5T; Lot or serial number: Not applicable.; Model or catalogue number: 781315
Affected products: Ingenia 1.5T; Lot or serial number: Not applicable.; Model or catalogue number: 1.5T
Affected products: Ingenia 3.0T CX; Lot or serial number: Not applicable.; Model or catalogue number: 781271
Affected products: Achieva 1.5T MRI System - Main Unit; Lot or serial number: Not applicable.; Model or catalogue number: ACHIEVA 1.5T
Affected products: Achieva 3.0T MRI System - Main Unit; Lot or serial number: Not applicable.; Model or catalogue number: ACHIEVA 3.0T
Affected products: Ingenia Ambition S; Lot or serial number: Not applicable.; Model or catalogue number: 782108
Affected products: Ingenia Ambition S; Lot or serial number: Not applicable.; Model or catalogue number: 782139
Affected products: Ingenia 3.0T; Lot or serial number: Not applicable.; Model or catalogue number: 3.0T
Affected products: Ingenia Ambition X; Lot or serial number: Not applicable.; Model or catalogue number: 782109
Affected products: Ingenia Ambition X; Lot or serial number: Not applicable.; Model or catalogue number: 781356
Affected products: Ingenia Ambition X; Lot or serial number: Not applicable.; Model or catalogue number: 782138
Affected products: Ingenia Elition X; Lot or serial number: Not applicable.; Model or catalogue number: 782107
Affected products: Ingenia Elition X; Lot or serial number: Not applicable.; Model or catalogue number: 781358
Affected products: Intera 1.5T MRI System - Main Unit; Lot or serial number: Not applicable.; Model or catalogue number: INTERA 1.5T
The hazard
Philips has become aware of a software issue affecting Philips Magnetic Resonance (MR) imaging systems operating with software versions R5 & R11, which may terminate an examination during the image reconstruction process. If the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory, the system will freeze, preventing image generation and requiring a system re-start.
What to do
Contact the manufacturer if you require additionl 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)