FDA-Device2025-03-05Class II
IntelePACS (Image Fusion Module) - InteleViewer
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.
Sold states
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
Affected count
88
Manufactured in
800, Boul. de Maisonneuve Est, 12th floor, Montreal, N/A, Canada
Products
IntelePACS (Image Fusion Module) - InteleViewer
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1208-2025Don't want to check this manually?
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