Recall Z-1884-2009 ยท LLZ System, Image Processing, Radiological
Intelerad Medical Systems Inc.
IntelePACS Picture Archiving Communications System InteleViewer Workstation Model #3.X.X.
| Date | Aug 27, 2009 (initiated Oct 27, 2008) |
| Status | Terminated |
| 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. |
| Root cause | 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 | 1 |
| Distribution | Worldwide Distribution -- United States (NM, AZ, CT, MN, TX, NC, TN, FL and CO), Canada, Australia, and New Zealand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070080 | INTELEPACS Intelerad Medical Systems, Inc., Jan 24, 2007 |