Recall Z-0155-05 ยท LLZ System, Image Processing, Radiological
GE OEC Medical Systems,Inc
Spine Clamp, an accessory to the InstaTrak 3500 Plus system. Clamp is attached to the spine to provide a mounting point for a transmitter.
| Date | Nov 3, 2004 (initiated Sep 15, 2004) |
| Status | Terminated |
| Reason | Threads on this accessory spine clamp may become tight, which may make it difficult to install or remove. |
| Root cause | Other |
| Action | Consignees were notified by letter on 9/15/2004. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040050 | INSTATRAK SYSTEM WITH MULTIPLE DATASET NAVIGATION, MODEL IT3500 Ge Medical Systems Navigation and Visualization IN, Mar 24, 2004 |