Recall Z-2040-2012 ยท OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
GE OEC Medical Systems, Inc
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
| Date | Jul 24, 2012 (initiated Nov 20, 2006) |
| Status | Terminated |
| Reason | Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. The OEC 6800 Miniview was recalled in November 2006 due to several intermittent potential safety issues including navigation tracking inaccuracy, system Lock-up, incorrect image display, incorrect dose area calculated air kerma in "film mo |
| Root cause | Device Design |
| Action | Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. On 11/20/2006, two written notifications were sent to 1513 identified consignees, addressed to the Facility Administrator and the Radiology Administrator for a combined total of 3026 letters. The Urgent Recall Notice, dated 11/8/2006, advised customers that GE Healthcare had identified several intermittent potential safety issues that may occur with the identified affected product. The notification also provided interim or permanent |
| Quantity | 1,933 units |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K992506 | MINI 6800 DIGITAL MOBILE C-ARM Ge Dec Medical Systems, Aug 19, 1999 |