Recall Z-0975-2017— GE OEC Medical Systems, Inc

Name: FDA recall Z-0975-2017
Creator: U.S. Food and Drug Administration
Published: 2016-12-19

Class II · Terminated

Class II FDA medical device recall by GE OEC Medical Systems, Inc, initiated 2016-12-19, terminated 2017-08-22. It names 2 FDA 510(k) clearances: K122234, K120613. Product: The OEC 9900 Elite mobile fluoroscopy system 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 discretionOEC 9900 Elite. MDL Numbers: D148942, D155043. Reason: GE Healthcare Surgery announces a voluntary field action for the OEC MiniView 6800, OEC 9900 Elite, and OEC 9800 because the workstation power cable assembly can result in intermittent power cord failures..

Recalling firm: GE OEC Medical Systems, Inc
Classification: Class II
Status: Terminated
Initiated: 2016-12-19
Terminated: 2017-08-22
Firm location: Salt Lake City, UT, United States

510(k) clearances named in this recall

2 on FDA's record

K122234 — OEC 9900 ELITEGe Healthcare Surgery GE Oec Medical Systems, Inc.·cleared 2012-08-16
K120613 — OEC 9900 ELITEGe Healthcare Surgery GE Oec Medical Systems, Inc.·cleared 2012-04-06

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 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 discretionOEC 9900 Elite. MDL Numbers: D148942, D155043

Reason for recall

GE Healthcare Surgery announces a voluntary field action for the OEC MiniView 6800, OEC 9900 Elite, and OEC 9800 because the workstation power cable assembly can result in intermittent power cord failures.

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