Radiological Image Processing System The system is an aid to locate anatomical structures during open or percutaneous su
FDA device recall Z-2136-2012 · posted 2012-08-08 · Terminated
Recall details
- Recalling firm
- GE OEC Medical Systems, Inc
- Reason for recall
- 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.
- Action taken
- 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,
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 17
- Distribution
- Worldwide Distribution - USA including MO, IL, LA, FL, NH, TX, IN, PA, NJ and the countries of France and China
- Date initiated
- 2007-04-02
- Date posted
- 2012-08-08
- Date terminated
- 2012-09-28
- Location
- Salt Lake City, UT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INSTATRAK 3000 SYSTEM WITH FLUOROTRAK MODULE, MODEL IT3000 (K994270) | Visualization Technology, Inc. | 2000-03-09 |