IntelePACS (Image Fusion Module)
Last updated
Summary
Product
IntelePACS (Image Fusion Module)
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| IntelePACS (Image Fusion Module) | Software version 5-6-1-P23 and later | INTELEPACS |
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
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Radiology
Companies
Intelerad Medical Systems Incorporated
800 Boulevard De Maisonneuve Est, Montreal, Quebec, Canada, H2L 4L8
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-76978
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