Recall Z-2629-2016 ยท OWB Interventional Fluoroscopic X-Ray System
GE OEC Medical Systems, Inc
OEC 9800, fluoroscopic x-ray system
| Date | Jul 22, 2016 |
| Status | Terminated |
| Reason | A firmware issue in the supplied LCD workstation monitor(s). Under some circumstances, the monitor(s) may appear dark with no video displayed. |
| Root cause | Software design (manufacturing process) |
| Action | On July 22, 2016 GE Healthcare Surgery began distributing an Urgent Medical Device Correction letter to customers via mail to inform them of the issue and provide instructions for immediate mitigation of the issue. The letter was sent to 3 titles at each facility affected: 1.) Facility Administrator, 2.) Director/Manager of Radiology and Radiologists, 3.) Radiology Department. Consignees instructured that local GE Healthcare Field Engineer will contact them to coordinate replacement of the affected monitor(s), and will ensure that system meets specifications. |
| Quantity | 47 total |
| Distribution | Distribution US nationwide and Korea. |
| 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 |
| K022069 | OEC FLUOROTRAK 9800 PLUS Ge Oec Medical Systems, Sep 17, 2002 |
| K111551 | OEC(R) 9800, OEC(R) 9800 PLUS Ge Oec Medical Systems, Inc., Oct 4, 2011 |
| K974355 | INTERVENTIONAL MOBILE DIGITAL IMAGING SYSTEM (HEREIN CALLED IMDIS) Ge Dec Medical Systems, Feb 17, 1998 |
| K993687 | UROVIEW 2800 Ge Dec Medical Systems, Dec 21, 1999 |