FDAFDA · Food and drugs·Recall number Z-2025-2012
OEC 9900 Elite, OEC 9900 Elite MD Motorized C-arm System, OEC 9900 Elite NAV used as an aid to locate anatomical structures during open or percutaneous surgical procedures. The system is an aid to locate anatomical structures during open or percutaneous surgical procedures. It is indicated for use in medical conditions that may benefit from the use of stereotactic surgery technique. The system provides a reference to rigid anatomical structures such as sinus, skull, long bone, or vertebra, which are visible on medical images such as CT, MRI, or X-ray.
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: 00-887200-01; 00-887200-03; 00-887201-01; 00-887201-03; 00-887202-01; 00-887202-03; 00-887204-03; 00-887207-03; 00-887206-03. Along with all associated serial numbers.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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