Recall Z-0813-05 ยท LLZ System, Image Processing, Radiological
GE OEC Medical Systems,Inc
ENTrak Plus Navigation and Visualization System
| Date | May 11, 2005 (initiated Jul 12, 2004) |
| Status | Terminated |
| Reason | Navigation inaccuracy may result if the headset registration method is used with the Axcess System Kit. |
| Root cause | Other |
| Action | Customers were notified by letter on 07/12/04. |
| Quantity | 2 kits |
| Distribution | Domestic distribution: VA, CT, KY, NJ, LA, PA, TN, OK, CA. Foreign distribution to Germany. There were no military or VA facilities. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K960330 | INSTATRAK Visualization Technology, Inc., Apr 8, 1996 |