GE Healthcare Navigation Pin Transmitter (GE P/N 1004070) -Medical Systems InstaTrak Pin Transmitter
FDA device recall Z-0709-06 · posted 2006-04-07 · Terminated
Recall details
- Recalling firm
- GE OEC Medical Systems,Inc
- Reason for recall
- Small retaining pin may detach and fall into the surgical field during stereotactic surgery.
- Action taken
- Consignees were notified by letter on 02/06/2006
- Root cause
- Other
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 186 units
- Distribution
- AL, AZ, CA, FL, GA, IL, IN, LA, MA, MD, MI, MN, MO, NJ, NV, NY, OR, PA, SC, TN, TX, UT, VA, WI, WV and one military facility in DC. Foreign distribution to Canada, Denmark, France Germany, Hong Kong,
- Date initiated
- 2006-02-06
- Date posted
- 2006-04-07
- Date terminated
- 2011-08-18
- 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 |
|---|---|---|
| OEC FLUOROTRAK 9800 PLUS (K022069) | Ge Oec Medical Systems | 2002-09-17 |
| INSTATRAK 3000 SYSTEM WITH FLUOROTRAK MODULE, MODEL IT3000 (K994270) | Visualization Technology, Inc. | 2000-03-09 |
| INSTATRAK 3000 (K983529) | Visualization Technology, Inc. | 1998-12-31 |