FDA-Device2012-07-04Class II
OEC Uroview 2800, Model number A349855. Designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures.
GE OEC Medical Systems, Inc
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.
Sold states
Worldwide Distribution.
Affected count
717 units
Manufactured in
384 Wright Brothers Dr, Salt Lake City, UT, United States
Products
OEC Uroview 2800, Model number A349855. Designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1865-2012Don't want to check this manually?
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