ProductGuru Recalls

Official recall record

IntelePACS (Image Fusion Module)

Health Canada — Medical Devices · 2025-02-19 · CanadaType II
Issuing authority
Health Canada — Medical Devices
Published
2025-02-19
Country of alert
Canada
Alert level
Type II
Alert type
recall

What the authority reported

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

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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