Recall Z-0001-2007 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
GE OEC Medical Systems, Inc
GE 4 inch Anterior Cervical Post, GE Part Number 1006385 or 1006385-NAV, GE Healthcare OEC Medical Systems (an accessory used with the InstaTrak 3500 plus and 9800 C-Arm Navigation systems)
| Date | Oct 3, 2006 (initiated May 31, 2006) |
| Status | Terminated |
| Reason | Weld defect- the weld between the post body and the screw was not properly formed and can fail, even when minimal force is used. |
| Root cause | Process control |
| Action | Consignees were notified by letter on 05/31/2006 |
| Quantity | 143 units |
| Distribution | Nationwide, including one VA facility in PA. No military distribution. Foreign distribution to Canada, China, Italy, Japan, Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K024012 | OEC 9800 E/CV+ DIGITAL MOBILE IMAGING SYSTEM Ge Oec Medical Systems, Mar 20, 2003 |