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GE OEC Medical Systems, Inc recalls The OEC 9900 Elite mobile fluoroscopy system (image intensified fluoroscopic x-ray) is designed to provide fluoroscopic
Recalled April 23, 2014 · FDA recall Z-1462-2014 · GE OEC Medical Systems
Hazard
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. · FDA Class II
Units
453 units
Sold at
Worldwide Distribution - USA, and the countries of Australia, Argentina, Canada, China, Cambodia, Columbia, Japan, Ecuador, Japan, Korea, Hong Kong, India, Israel, Libya, Mexico, Nigeria, Peru, Russia, Thailand, Taiwan, Saudi Arabia and Singapore.
Description
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.
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.
Manufacturer(s)
GE OEC Medical Systems, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →