The FDA's Center for Devices & Radiological Health has issued a Class I recall of GE's FluoroTrak Spinal Navigation System. The federal agency recalled the device as the system application on the OEC 9900 EliteNAV could result in an incorrect position of the navigated instruments versus the displayed reference image. This issue could result in an injury to the patient due to incorrect anatomical location of the instrument during a procedure.
GE initially voluntarily recalled the device in 2007.
GE initially voluntarily recalled the device in 2007.
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