Recall Z-2065-2012 ยท OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
GE OEC Medical Systems, Inc
OEC 8800 Flexview, 892.1650 Image-intensified fluoroscopic x-ray system Product Usage: The 8800 Flexview is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures. Clinical applications may include cholangiography, urologic, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room
| 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 8800 Flexview was recalled in November 2006 due to several intermittent potential safety issues including navigation tracking inaccuracy, system lok-up, incorrect image display, incorrect dose area calculated air kerma in "film mod |
| 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. GE Healthcare sent two Urgent Recall Notice letters to the Facility Administrator and the Radiology Administrator. The letters identified the affected product, problem and actions to be taken. The letters advised consignees that GE Healthcare is actively working on solutions that will permanently resolve each of the issues. For questions or concerns contact GE Healthcare service team at 800-874-7378 option 8. |
| Quantity | 1257 units (472 domestic systems) |
| Distribution | Worldwide Distribution - US Nationwide |
| 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 |