Philips Ingenia, Achieva and Intera MR Systems recall

Health product recall

Philips Ingenia, Achieva and Intera MR Systems

 

Brand(s)

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

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

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Date modified:

2026-09-17