Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
IntelePACS (Image Fusion Module) - InteleViewer Recalled by INTELERAD MEDICAL SYSTEMS INCORPORATED Due to A software application that receives digital images and...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact INTELERAD MEDICAL SYSTEMS INCORPORATED directly.
Affected Products
IntelePACS (Image Fusion Module) - InteleViewer
Quantity: 88
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About INTELERAD MEDICAL SYSTEMS INCORPORATED
INTELERAD MEDICAL SYSTEMS INCORPORATED has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report