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Health Canada Medical devices

MIM (Software Package)

Issued March 7, 2025
Issue
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
Hazard description
Performance
Product
Product name
MIM (Software Package)
Reference
ID
RA-77076