FDA-Device2012-08-08Class II
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 for other imaging applications at the physician's discretion.
GE OEC Medical Systems, Inc
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 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
Sold states
Worldwide Distribution - US (nationwide) and the countries of: Canada, France, Japan, and China.
Affected count
Part of a total of 82 units.
Manufactured in
384 Wright Brothers Dr, N/A, Salt Lake City, UT, United States
Products
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 for other imaging applications at the physician's discretion.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2127-2012Don't want to check this manually?
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