Reported Mar 5, 2025 · Ongoing
IntelePACS (Image Fusion Module) - InteleViewer
Intelerad Medical Systems Incorporated
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: INTELERAD MEDICAL SYSTEMS INCORPORATED · 800, Boul. de Maisonneuve Est · Montreal, N/A · N/A
Is this the product you have?
- IntelePACS (Image Fusion Module) - InteleViewer
- Lot codes and dates
- UDI-DIB228INTELEPACS0
- Device Versions5-6-1-P23 and later
- Amount recalled
- 88
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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