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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 System see related information
Date Initiated by Firm October 27, 2008
Date Posted August 27, 2009
Recall Status1 Terminated 3 on September 24, 2010
Recall Number Z-1885-2009
Recall Event ID 52761
510(K)Number K070080  
Product Classification System, image processing, radiological - Product Code LLZ
Product IntelePACS Picture Archiving Communications System InteleViewer module, 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.
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
Action Intelerad 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 Commerce 17 (including 11 free trials)
Distribution Worldwide Distribution -- United States (NM, AZ, CT, MN, TX, NC, TN, FL and CO), Canada, Australia, and New Zealand.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = LLZ and Original Applicant = INTELERAD MEDICAL SYSTEMS INC.
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