INTELERAD MEDICAL SYSTEMS INCORPORATED recalls IntelePACS (Image Fusion Module) - InteleViewer

Recall date

February 5, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1208-2025

FDA classification

Class II

Brand / firm

INTELERAD MEDICAL SYSTEMS INCORPORATED

Sold / distributed

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

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

IntelePACS (Image Fusion Module) - InteleViewer