Recall Z-2125-2012 ยท IZL System, X-Ray, Mobile
GE OEC Medical Systems, Inc
OEC 9800 Plus Digital; MDL number A349855. Product Usage: Is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging appl
| Date | Aug 1, 2012 (initiated Mar 27, 2007) |
| 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. GE OEC had discovered an issue with the hard disk drives that were installed on OEC device models: UroView 2800; 9800 Plus Digital; MiniView 6800; and FlexiView 8800 Mobile C-Arm. The devices were manufactured between October 15, 2004 and |
| 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. GE OEC sent an Urgent Safety Advisory Notices dated October 11, 2006 and February 21, 2007 via certified mail delivery letter to affected customers. The notices identified the affected products, problem and actions to be taken. Customers were informed that a GEHC OEC field service engineer would be contacting their facility to arrange to have a replacement hard disk drive installed on the affected system(s). Customers were instructe |
| Quantity | Part of a total of 82 units distributed. |
| Distribution | Worldwide Distribution - US (nationwide) and the countries of: Canada, France, Japan, and China. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021049 | OEC 9800 PLUS DIGITAL MOBILE IMAGING SYSTEM Ge Oec Medical Systems, Apr 17, 2002 |