GE OEC Medical Systems, Inc: 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.

Agency Publication Date: January 9, 2017

Affected Products

Product: OEC 9800. MDL Numbers: D222250, D141598 The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.

Manufactured between 1/1/16 to 11/1/16

Product: OEC MiniView 6800. MDL Number: D002533 The OEC MiniView 6800 Digital Mobile C-Arm is designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imaging. The device is not intended for whole-body pediatric imaging

Manufactured between 1/1/16 to 11/1/16

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

Manufactured between 1/1/16 to 11/1/16

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 76033

Status: Resolved

Manufacturer: GE OEC Medical Systems, Inc

Manufactured In: United States

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Sources: FDA iRES · Raw API Response

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Affected Products

Manufactured between 1/1/16 to 11/1/16