IntelePACS Picture Archiving Communications System InteleViewer Workstation Model #3.X.X.
FDA Recall Z-1884-2009 · Posted 2009-08-27
Recalling FirmIntelerad Medical Systems Inc.
Recall StatusTerminated
Product CodeLLZ
Date Initiated2008-10-27
Date Terminated2010-09-24
Product Quantity1
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.
Firm 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 [email protected].
For further information, contact Intelerad Medical Systems at 1-514-931-6222.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution -- United States (NM, AZ, CT, MN, TX, NC, TN, FL and CO), Canada, Australia, and New Zealand.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.