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INTELERAD MEDICAL SYSTEMS INCORPORATED recalls IntelePACS (Image Fusion Module) - InteleViewer
Recalled March 5, 2025 · FDA recall Z-1208-2025 · INTELERAD MEDICAL SYSTEMS INCORPORATED
Hazard
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. · FDA Class II
Units
88
Sold at
Worldwide - US Nationwide distribution in the states of AZ, NC, MI, FL, NH, WY, CA, SC, AL, AR, IN, MD, CO, TN, IL, NJ, OH, MN, WV, KE, NE, VA, WA, GE, WI and the countries of New Zealand, Canada, Australia
Description
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.
Product
IntelePACS (Image Fusion Module) - InteleViewer
Manufacturer(s)
INTELERAD MEDICAL SYSTEMS INCORPORATED
Made in
Canada
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →