medical Class II Updated 2025-03-05

INTELERAD MEDICAL SYSTEMS INCORPORATED recalls IntelePACS (Image Fusion Module) - InteleViewer

Recalled Product

IntelePACS (Image Fusion Module) - InteleViewer

Hazard / Issue

A software application that receives digital images and data from various sources has a bug in specific software versions that will calculate the Standard Uptake Value (SUV) incorrectly for PET/CT studies acquired on the days of Daylight Savings Time (DST); only on dates in which DST transition occurs; all other dates are unaffected. An incorrect SUV may lead to an incorrect diagnosis.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI: B228INTELEPACS0, Device Versions: 5-6-1-P23 and later
View official government recall

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