Home / Recalls / INTELERAD MEDICAL SYSTEMS INCORPORATED / Z-1208-2025

Z-1208-2025 Class II Ongoing

Recalled by INTELERAD MEDICAL SYSTEMS INCORPORATED — Montreal, N/A

Recall Details

Product Type: Devices
Report Date: March 5, 2025
Initiation Date: February 5, 2025
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 88

Product Description

IntelePACS (Image Fusion Module) - InteleViewer

Reason for Recall

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.

Distribution Pattern

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

Code Information

UDI-DI: B228INTELEPACS0, Device Versions: 5-6-1-P23 and later