FDA-Device2012-08-08Class II
OEC MiniView 6800 Mobile; MDL number A349855. Product Usage: The mini 6800 digital mobile c arm is designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical, orthopedic, and extremity imaging. The device is not intended for whole body pediatric imaging.
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 distributed.
Manufactured in
384 Wright Brothers Dr, N/A, Salt Lake City, UT, United States
Products
OEC MiniView 6800 Mobile; MDL number A349855. Product Usage: The mini 6800 digital mobile c arm is designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical, orthopedic, and extremity imaging. The device is not intended for whole body pediatric imaging.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2126-2012Don't want to check this manually?
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