IntelePACS Picture Archiving Communications System InteleViewer Workstation Model #3.X.X.
This recall has been terminated (originally issued August 27, 2009).
- Recall Initiated
- October 27, 2008
- Posted
- August 27, 2009
- Terminated
- September 24, 2010
- Recall Number
- Z-1884-2009
- Quantity
- 1
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide Distribution -- United States (NM, AZ, CT, MN, TX, NC, TN, FL and CO), Canada, Australia, and New Zealand.
Lot / Code Info
InteleViewer software versions 3.5.2.P1 to 3.3.2.P56 inclusive and 3.6.1.P1 to 3.6.1.P82 inclusive.
Root Cause
Software design
Action Taken
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.