FDA Recall
Terminated
IntelePACS Picture Archiving Communications System InteleViewer module, Model #3.X.X.
Recall: Z-1885-2009
·
Initiated October 27, 2008
Recall
- Recall Number
- Z-1885-2009
- Event Number
- 52761
- Firm
- Intelerad Medical Systems Inc. 460 Ste-Catherine West Suite 210 Montreal Canada
- FEI Number
- 3003768392
- Product Code
- LLZ
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- October 27, 2008
- Posted
- August 27, 2009
- Terminated
- September 24, 2010
Description
IntelePACS Picture Archiving Communications System InteleViewer module, Model #3.X.X.
Reason
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.
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.
Distribution
Worldwide Distribution -- United States (NM, AZ, CT, MN, TX, NC, TN, FL and CO), Canada, Australia, and New Zealand.
Quantity
17 (including 11 free trials)