Recall MonitorHealth Products
Philips Ingenia, Achieva and Intera MR Systems
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Radiology
Product: Philips Ingenia, Achieva and Intera MR Systems
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
Products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Intera 1.5T MRI System- Main Unit | Not applicable. | INTERA 1.5T |
| Ingenia Ambition X | Not applicable. | 782109 |
| Ingenia Ambition X | Not applicable. | 782138 |
| Ingenia 3.0T CX | Not applicable. | 781271 |
| Ingenia 3.0T | Not applicable. | 3.0T |
| Achieva 3.0T MRI System- Main Unit | Not applicable. | ACHIEVA 3.0T |
| Ingenia Elition X | Not applicable. | 782136 |
| Ingenia Elition X | Not applicable. | 781358 |
Issue
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.