Recall Z-2038-2012 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
GE OEC Medical Systems, Inc
OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging proce
| Date | Jul 24, 2012 (initiated Feb 22, 2008) |
| 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 vertical lift column power supply in the mainframe C-arm of the device is defective and subject to early life failure. |
| Root cause | Software 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. The firm, GE Healthcare, Surgery, sent an "URGENT RECALL NOTICE" dated November 8, 2006 via certified mail with return receipt request to consignees/customers with specific instructions. Customers were advised "to stop using the system WITH NAVIGATION until this replacement has been successfully completed. OEC@ FluoroTrak 9800 Plus system may be used as a standard C-Arm providing you review the other issues as listed below." GEHC OEC |
| Quantity | 8214 units |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |