FDAFDA · Food and drugs·Recall number Z-2026-2012
OEC 9800, OEC FluoroTrak 9800 Plus, OEC 9800 Plus, OEC 9800 MD Motorized C-arm System designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures, and is also intended for cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.
Published July 25, 2012 · Recall initiated: November 19, 2007
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being classified by the Agency. GE OEC recalled imaging devices OEC 9900, OEC 9800, and OEC 8800 as a result of an FDA inspection identifying that the vertical lift column power supply in the mainframe C-arm is defective and subject to early life failure.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- GE OEC Medical Systems, Inc
- Distributor
- Worldwide Distribution.
- Lot
- Part numbers: 00-884909-01, 00-884777-01, 00-884911-01, 00-885553-01, 00-884913-01, 00-885554-01, 00-885555-01, 00-886289-01. All serial numbers.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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