Philips Ingenia and Achieva MRI Systems - MRE Liver Stiffness Measurement Recall
Summary
Health Canada has issued a Type I recall for Philips Ingenia and Achieva MRI Systems following identification of two software issues affecting diagnostic accuracy. The primary issue involves MRE (Magnetic Resonance Elastography) stiffness measurements where default scan protocol voxel size settings are too small, potentially producing inaccurate (lower) liver stiffness values. A secondary issue affects Philips Vue Motion v12.2.0-v12.2.8.500 where mis-ordered image frames during dynamic cine runs may display out of sequence. Affected products include multiple Ingenia and Achieva 3.0T models with specific lot numbers.
What changed
Health Canada has issued a Type I recall affecting Philips Ingenia 1.5T, Ingenia Elition X, Ingenia Ambition X, and Achieva 3.0T MRI Systems. The primary defect involves MRE stiffness measurements where reconstruction voxel size settings in default protocols are too small, potentially producing inaccurately low liver stiffness values. A secondary software defect affects Philips Vue Motion v12.2.0 through v12.2.8.500, where mis-ordered frames during dynamic cine runs may cause images to display out of sequence.\n\nHealthcare facilities using these MRI systems should be aware that MRE-derived liver stiffness measurements may be unreliable for diagnostic purposes. Clinical decisions based on affected measurements should be reconsidered. Contact Philips Medical Systems for additional information regarding software corrections and protocol updates. Type I classification indicates reasonable probability of serious adverse health consequences if the defect is not addressed.
What to do next
- Contact the manufacturer if you require additional information
Archived snapshot
Apr 17, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Health product recall
Ingenia and Achieva Systems
Brand(s)
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
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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