Recall Monitor
Health Products

IntelePACS (Image Fusion Module)

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Radiology
Product: IntelePACS (Image Fusion Module)
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalog number
IntelePACS (Image Fusion Module)Software version 5-6-1-P23 and laterINTELEPACS

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

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