CanadaPhilips Ingenia, Achieva and Intera MR systems (including INTERA 1.5T; Ingenia Ambition X models 782109 and 782138; Ingenia 3.0T CX model 781271 and Ingenia 3.0T model 3.0T; Ingenia Elition X models 782136 and 781358; Achieva 3.0T) are affected when exporting diffusion tensor imaging (DTI) scans using the Enhanced MR DICOM format. These exports contain incorrect diffusion direction data, which can prevent third‑party tractography software from correctly reconstructing nerve‑fiber pathways. 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: Intera 1.5T MRI System- Main Unit; Lot or serial number: Not applicable.; Model or catalogue number: INTERA 1.5T
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: 782138
Affected products: Ingenia 3.0T CX; Lot or serial number: Not applicable.; Model or catalogue number: 781271
Affected products: Ingenia 3.0T; Lot or serial number: Not applicable.; Model or catalogue number: 3.0T
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 Elition X; Lot or serial number: Not applicable.; Model or catalogue number: 782136
Affected products: Ingenia Elition X; Lot or serial number: Not applicable.; Model or catalogue number: 781358
The hazard
When exporting diffusion tensor imaging (DTI) scans from a Philips MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is used in conjunction with third-party software for tractography (e.g. for mapping nerve fiber pathways in the brain), the software will not be able to correctly process the DTI data for reconstruction.
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)