Recall Z-0678-2007 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
GE OEC Medical Systems, Inc
OEC 8800 image-intensified fluoroscopic x-ray system, GE Healthcare, Salt Lake City, UT.
| Date | Sep 28, 2007 (initiated Mar 1, 2007) |
| Status | Terminated |
| Reason | During routine service, primary and/or secondary collimators may not have been properly reinstalled. |
| Root cause | Other |
| Action | Customers were notified by letter on 03/01/2007. They were told to continue using the machines and that an inspection would be scheduled immediately to verify that collimators had been correctly installed. |
| Quantity | 17 units |
| Distribution | Nationwide and Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K003837 | FLEXIVIEW 8800 DIGITAL MOBILE IMAGING SYSTEM Ge Oec Medical Systems, Mar 12, 2001 |