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Recall Observatory FDA recall evidence

Device 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.

Z-1462-2014

March 31, 2014

Class II

Product summary

Firm
GE OEC Medical Systems, Inc
Event
Event 67867
Status
Terminated
Classification
Class II
Quantity
453 units
Official record key
device-enforcement:Z-1462-2014

Official wording

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.

Code information: Model Numbers - OEC 9900 Elite

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.