Company: INTELERAD MEDICAL SYSTEMS INCORPORATED
Date of Enforcement Report: 2/25/2025
Class II
PRODUCT
IntelePACS (Image Fusion Module) – InteleViewer
Recall Number:
Z-1208-2025
REASON:
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.
RECALLING FIRM/MANUFACTURER:
INTELERAD MEDICAL SYSTEMS INCORPORATED
VOLUME OF PRODUCT IN COMMERCE:
88
DISTRIBUTION:
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
