Recall Z-2136-2012 ยท LLZ System, Image Processing, Radiological
GE OEC Medical Systems, Inc
Radiological Image Processing System The system is an aid to locate anatomical structures during open or percutaneous surgical procedures. It is indicated for use in medical conditions that may benefit from the use of stereotactic surgical technique. The system provides a reference to rigid anatomical structures such as sinus, skull, long bone, or vertebra, which are visible on medical images suc
| Date | Aug 8, 2012 (initiated Apr 2, 2007) |
| Status | Terminated |
| Reason | The FluoroTrak Spinal Navigation Application on the OEC 9900 EliteNAV could result in an incorrect position of the navigated instrument(s) versus the displayed reference image. |
| Root cause | Software design |
| Action | GE Healthcare sent an Urgent Recall Notice dated April 2, 2007, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers with questions were asked to call 800-874-7378. For questions regarding this recall call 801-536-4952, |
| Quantity | 17 |
| Distribution | Worldwide Distribution - USA including MO, IL, LA, FL, NH, TX, IN, PA, NJ and the countries of France and China |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K994270 | INSTATRAK 3000 SYSTEM WITH FLUOROTRAK MODULE, MODEL IT3000 Visualization Technology, Inc., Mar 9, 2000 |