CFIA - Canadian Food Inspection Agency

04/16/2026 | Press release | Distributed by Public on 04/16/2026 13:49

Ingenia and Achieva Systems

Health product recall

Ingenia and Achieva Systems

Last updated
2026-04-16

Summary

Product
Ingenia and Achieva 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
Ingenia 1.5T 70851 1.5T
Ingenia Elition X 45052 781358
Ingenia Elition X 45590 782107
Ingenia Elition X 62158 782107
Ingenia Ambition X 49004 782138
Achieva 3.0T MRI System - Main Unit 17385 ACHIEVA 3.0T
Achieva 3.0T MRI System - Main Unit 38109 ACHIEVA 3.0T

Issue

Philips has become aware through the MRE software system developer Resoundant about an issue affecting MRE stiffness measurements when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm. Specifically, the reconstruction voxel size settings in the default MRE scan protocol are too small, which can potentially lead to inaccurate liver stiffness measurements (lower values).

Philips has identified a software issue affecting Philips Vue Motion v12.2.0 - v12.2.8.500 where mis-ordered frames in Vue Motion during dynamic cine runs may cause images frames to display out of sequence.

Additional information

Details
Original published date: 2026-04-16
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 I
Recall date
2026-04-15
Identification number
RA-81905

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CFIA - Canadian Food Inspection Agency published this content on April 16, 2026, and is solely responsible for the information contained herein. Distributed via Public Technologies (PUBT), unedited and unaltered, on April 16, 2026 at 19:49 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 If you believe the information included in the content is inaccurate or outdated and requires editing or removal, please contact us at [email protected]