Recall Z-0094-04 ยท LLZ System, Image Processing, Radiological
Philips Medical Systems (Cleveland) Inc
Philips Odyssey FX Workstations, used with Axis, Irix, or Meridian Gamma Camera Systems.
| Date | Nov 6, 2003 (initiated Sep 15, 2003) |
| Status | Terminated |
| Reason | Due to a software anomaly, an incorrect patient name may be transmitted with image to Odyssey workstation. |
| Root cause | Other |
| Action | The firm notified their affected consignees by letter on 9/15/2003. The customers were informed how to avoid the problem until a software upgrade is installed on the units. |
| Quantity | 1,334 units installed |
| 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
This recall record lists no 510(k) number.