Recall Z-0889-06 ยท LLZ System, Image Processing, Radiological
Philips Medical Systems (Cleveland) Inc
Extended Brilliance Workspace Imaging Workstation. An independent diagnostic viewing and processing workstation, for CT images.
| Date | May 19, 2006 (initiated Aug 2, 2004) |
| Status | Terminated |
| Reason | Due to a software deficiency that occurs in the combine mode, a patients image can be filmed over a different patients image. |
| Root cause | Other |
| Action | Revised, corrected software has been shipped to consignees beginning June, 2004. |
| Quantity | 397 devices. |
| Distribution | The systems were installed at medical facilities located nationwide and worldwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012009 | MX8000 IDT CT SYSTEM Marconi Medical Systems, Inc., Sep 13, 2001 |