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Official recall record

Ingenia and Achieva Systems

Health Canada — Medical Devices · 2026-04-16 · CanadaType I
Issuing authority
Health Canada — Medical Devices
Published
2026-04-16
Country of alert
Canada
Alert level
Type I
Alert type
recall

What the authority reported

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).

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

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