UroView 2800; MDL number A349855 — recall Z-2127-2012
U.S. FDA — Device Enforcement · United States · 2007-03-27 · Class II
As described by U.S. FDA — Device Enforcement: UroView 2800; MDL number A349855. Product Usage: Designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures. Clinical application may include but are not limited to urologic and endoscopic procedures. The system may be ued fo
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Terminated — the recall action is complete and the FDA has closed it
Initiated by
FDA Mandated
Distribution
Worldwide Distribution - US (nationwide) and the countries of: Canada, France, Japan, and China.
Reported risk: 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 had discovered an issue with the hard disk drives that were installed on OEC device models: UroView 2800; 9800 Plus Digital; MiniView 6800; and FlexiView 8800 Mobile C-Arm. The devices were manufactured between October 15, 2004 and
Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.
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