Product Wiki · Recalls · Health Canada — Medical Devices

IntelePACS (Image Fusion Module) — recall 76978

Health Canada — Medical Devices · Canada · 2025-02-19 · Type II

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
Health Canada — Medical Devices
Recall identifier
76978
Date of alert
2025-02-19
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Radiology
Product type
Medical devices
Reported risk: 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
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/intelepacs-image-fusion-module

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

Related

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.