CFIA - Canadian Food Inspection Agency
CFIA - Canadian Food Inspection Agency
09/17/2026 | Press release | Distributed by Public on 09/17/2026 08:32
Philips Ingenia, Achieva and Intera MR Systems
Health product recall
Philips Ingenia, Achieva and Intera MR Systems
Last updated
2026-09-17
Summary
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
Affected 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.
Additional information
Details
Original published date: 2026-09-17
Alert / recall type
Health product recall
Category
Health products - Medical devices - Radiology
Companies
Philips Medical Systems Nederland B.V.
Veenpluis 6, Best, Netherlands, 5684 PC
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
2026-09-04
Identification number
RA-82636
Get notified
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Date modified: 2026-09-17
CFIA - Canadian Food Inspection Agency published this content on September 17, 2026, and is solely responsible for the information contained herein. Distributed via Public Technologies (PUBT), unedited and unaltered, on September 17, 2026 at 14:32 UTC. If you believe the information included in the content is inaccurate or outdated and requires editing or removal, please contact us at [email protected]