Recall Z-1208-2025— INTELERAD MEDICAL SYSTEMS INCORPORATED

Name: FDA recall Z-1208-2025
Creator: U.S. Food and Drug Administration
Published: 2025-02-05

Class II · Ongoing

Class II FDA medical device recall by INTELERAD MEDICAL SYSTEMS INCORPORATED, initiated 2025-02-05. It names one FDA 510(k) clearance: K192176. Product: IntelePACS (Image Fusion Module) - InteleViewer. 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: INTELERAD MEDICAL SYSTEMS INCORPORATED
Classification: Class II
Status: Ongoing
Initiated: 2025-02-05
Firm location: Montreal, N/A, Canada

510(k) clearances named in this recall

1 on FDA's record

K192176 — IntelePACSIntelerad Medical Systems Incorporated·cleared 2020-04-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.