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U.S. Department of Health and Human Services

Class 2 Device Recall IntelePACS Picture Archiving Communications System

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 Class 2 Device Recall IntelePACS Picture Archiving Communications Systemsee related information
Date Initiated by FirmOctober 27, 2008
Date PostedAugust 27, 2009
Recall Status1 Terminated 3 on September 24, 2010
Recall NumberZ-1884-2009
Recall Event ID 52761
510(K)NumberK070080 
Product Classification System, image processing, radiological - Product Code LLZ
ProductIntelePACS Picture Archiving Communications System InteleViewer Workstation Model #3.X.X.
Code Information InteleViewer software versions 3.5.2.P1 to 3.3.2.P56 inclusive and 3.6.1.P1 to 3.6.1.P82 inclusive.
FEI Number 3003768392
Recalling Firm/
Manufacturer		 Intelerad Medical Systems Inc.
460 Ste-Catherine West
Suite 210
Montreal Canada
Manufacturer Reason
for Recall		Product software versions 3.5.2.P1 to 3.5.2.p56 inclusive and 3.6.1.P1 to 3.6.1.P82 inclusive were defective.
FDA Determined
Cause 2		Software design
ActionIntelerad Medical Systems issued an Urgent Medical Device Filed Safety Notice" dated October 24, 2008 describing the affected product and steps required for system upgrade. Users are requested to complete and return an acknowledgement form via email to quality@intelerad.com. For further information, contact Intelerad Medical Systems at 1-514-931-6222.
Quantity in Commerce1
DistributionWorldwide Distribution -- United States (NM, AZ, CT, MN, TX, NC, TN, FL and CO), Canada, Australia, and New Zealand.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
510(K) Database510(K)s with Product Code = LLZ
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