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INTELERAD MEDICAL SYSTEMS INCORPORATED
1 federal recall on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for INTELERAD MEDICAL SYSTEMS INCORPORATED and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-03-05FDA-DeviceClass IIIntelePACS (Image Fusion Module) - InteleViewer
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.
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