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U.S. Department of Health and Human Services

Class 2 Device Recall IntelePACS Image fusion module

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 Class 2 Device Recall IntelePACS Image fusion modulesee related information
Date Initiated by FirmFebruary 05, 2025
Date PostedFebruary 21, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1208-2025
Recall Event ID 96270
510(K)NumberK192176 
Product Classification System, image processing, radiological - Product Code LLZ
ProductIntelePACS (Image Fusion Module) - InteleViewer
Code Information UDI-DI: B228INTELEPACS0, Device Versions: 5-6-1-P23 and later
FEI Number 3003768392
Recalling Firm/
Manufacturer		 INTELERAD MEDICAL SYSTEMS INCORPORATED
800, Boul. de Maisonneuve Est
12th floor
Montreal Canada
Manufacturer 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.
FDA Determined
Cause 2		Software design
ActionOn 2/5/2025, correction notices were emailed to customers who were asked to do the following: The following work around can be completed for any impacted SUV calculation. The correct SUV values may be obtained in the SUV calculator, as follows: 1. Adjust the administration time and series time in IntelePACS consistent with the actual time of injection and the time of series acquisition. 2. Verify that the calculated elapsed time is correct. 3. Recalculate the SUV in the calculator, this is the correct SUV value. - Customers are asked to review scans and notify the recalling firm if scans were performed on Daylight Savings Time dates since 2022. - A software upgrade to eliminate this bug is expected to be released by the end of March 2025. Once available, you will be notified via email. You will then be able to schedule your product upgrade. - Complete and return the acknowledgement form via email to regulatory-affairs@intelerad.com For more information or to ask any questions about this notification, please contact the firm's regulatory affairs department at regulatory-affairs@intelerad.com
Quantity in Commerce88
DistributionWorldwide - 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
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = LLZ
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