Spine Clamp, an accessory to the InstaTrak 3500 Plus system. Clamp is attached to the spine to provide a mounting point
FDA device recall Z-0155-05 · posted 2004-11-03 · Terminated
Recall details
- Recalling firm
- GE OEC Medical Systems,Inc
- Reason for recall
- Threads on this accessory spine clamp may become tight, which may make it difficult to install or remove.
- Action taken
- Consignees were notified by letter on 9/15/2004.
- Root cause
- Other
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 114 units
- Distribution
- AL, CO, CA, FL, GA, LA, IL, IN, MA, MD, MI, MS, NC, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WI, WV, including one VA facility in TN. No military or foreign distribution.
- Date initiated
- 2004-09-15
- Date posted
- 2004-11-03
- Date terminated
- 2011-07-07
- 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 SYSTEM WITH MULTIPLE DATASET NAVIGATION, MODEL IT3500 (K040050) | Ge Medical Systems Navigation and Visualization IN | 2004-03-24 |