Official recall record
MIM (Software Package)
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2025-03-07
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
In situations where two images with differing fields of view (FOV) complete an image fusion, an incorrect, elevated maximum standardized uptake value (SUV) could result. This could lead to mistaken assessment of disease status, progression or response to treatment and potential inappropriate therapy. Recall Start Date: February 21, 2025
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.
Record last checked against the registry on 2026-05-31.
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