Recall Z-1462-2014— GE OEC Medical Systems, Inc

Name: FDA recall Z-1462-2014
Creator: U.S. Food and Drug Administration
Published: 2014-03-31

Class II · Terminated

Class II FDA medical device recall by GE OEC Medical Systems, Inc, initiated 2014-03-31, terminated 2015-10-26. It names 3 FDA 510(k) clearances: K082781, K073543, K061953. Product: The OEC 9900 Elite mobile fluoroscopy system (image intensified fluoroscopic x-ray) is designed to provide fluoroscopic and spot-film images of the patient during diagnostic surgical and interventional procedure. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedure. The system may be used for other imaging applications at the physician's discretion.. Reason: GE Healthcare has identified a potential safety issue related to the screws that attach the workstation monitor spring arm to the extension arm on certain OEC 9900 systems, causing the spring arm and monitor to fall forward..

Recalling firm: GE OEC Medical Systems, Inc
Classification: Class II
Status: Terminated
Initiated: 2014-03-31
Terminated: 2015-10-26
Firm location: Salt Lake City, UT, United States

510(k) clearances named in this recall

3 on FDA's record

K082781 — OEC 9900 ELITEGe Healthcare Surgery·cleared 2009-05-01
K073543 — OEC 9900 ELITEGe Oec Medical Systems·cleared 2008-05-02
K061953 — 9900 PLUS MOBILE FLUOROSCOPY SYSTEM WITH 3D AND NAVIGATION OPTIONSGe Oec Medical Systems·cleared 2006-08-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

The OEC 9900 Elite mobile fluoroscopy system (image intensified fluoroscopic x-ray) is designed to provide fluoroscopic and spot-film images of the patient during diagnostic surgical and interventional procedure. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedure. The system may be used for other imaging applications at the physician's discretion.

Reason for recall

GE Healthcare has identified a potential safety issue related to the screws that attach the workstation monitor spring arm to the extension arm on certain OEC 9900 systems, causing the spring arm and monitor to fall forward.

Data sourced from openFDA. This site is unofficial and independent of the FDA.