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Health Canada Medical devices

IntelePACS (Image Fusion Module)

Issued February 19, 2025
Issue
An incorrect SUV (standard uptake value) calculation occurs in the PET/CT fusion viewer module. This issue only occurs on days with a DST (daylight savings time) change. The issue occurs because the calculation relies on a time calculation which does not correctly consider the DST change. An incorrect SUV may lead to an incorrect diagnosis. Recall start date: February 4, 2025
Hazard description
Performance
Product
Product name
IntelePACS (Image Fusion Module)
Reference
ID
RA-76978