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GE OEC Medical Systems, Inc recalls OEC Uroview 2800, Model number A349855. Designed to provide fluoroscopic and spot-film imaging of the patient durin
Recalled July 4, 2012 · FDA recall Z-1865-2012 · GE OEC Medical Systems
Hazard
Recalled in November 2006 due to several intermittent potential safety issues including navigation tracking inaccuracy, system Lok-up, incorrect image display, incorrect dose area calculated air kerma in "film mode" and "digital spot mode", and the system does not reboot. · FDA Class II
Units
717 units
Sold at
Worldwide Distribution.
Description
Recalled in November 2006 due to several intermittent potential safety issues including navigation tracking inaccuracy, system Lok-up, incorrect image display, incorrect dose area calculated air kerma in "film mode" and "digital spot mode", and the system does not reboot.
Product
OEC Uroview 2800, Model number A349855. Designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures.
Manufacturer(s)
GE OEC Medical Systems, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →