ENTrak Navigation and Visualization System
FDA device recall Z-0812-05 · posted 2005-05-11 · Terminated
Recall details
- Recalling firm
- GE OEC Medical Systems,Inc
- Reason for recall
- Navigation inaccuracy may result if the headset registration method is used with the Axcess System Kit.
- Action taken
- Customers were notified by letter on 07/12/04.
- Root cause
- Other
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 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.
- Date initiated
- 2004-07-12
- Date posted
- 2005-05-11
- Date terminated
- 2011-08-02
- 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 (K960330) | Visualization Technology, Inc. | 1996-04-08 |