INTELERAD MEDICAL SYSTEMS INCORPORATED: Device Recall

Recall #Z-1208-2025 · 02/05/2025

Class II: Risk

Recall Details

Recall Number: Z-1208-2025
Classification: Class II
Product Type: Device
Recalling Firm: INTELERAD MEDICAL SYSTEMS INCORPORATED
Status: Ongoing
Date Initiated: 02/05/2025
Location: Montreal, N/A, Canada
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 88

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.

Product Description

IntelePACS (Image Fusion Module) - InteleViewer

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

Other Recalls by INTELERAD MEDICAL SYSTEMS INCORPORATED

Class II: Risk 10/17/2025

Software application that receives digital images and data to be communicated, processed, manipulated, enhanced, stored, displayed has a bug that could cause data loss in Relevant Clinical Info field when modifying studies through Case Editor in either Technologist Portal or Referring Physician Portal, which could result in loss of clinical information, which could impact clinical decision-making.

View all recalls by INTELERAD MEDICAL SYSTEMS INCORPORATED →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.