FDA-Device2015-01-21Class II
GE OEC Brivo 715 Prime Mobile C-Arm X-Ray Product Used for general surgical applications and musculoskeletal procedures to visualize.
GE OEC Medical Systems, Inc
Hazard
mA Accuracy may exceed the design and labeling specification of+ 10%. Per 1020.32(f): Deviation of x-ray tube potential and current from the indicated values shall not exceed the maximum deviation as stated by the manufacturer in accordance with 1020.30(h)(3).
Sold states
Worldwide Distribution
Affected count
61 units installed in US
Manufactured in
384 N Wright Brothers Dr, Salt Lake City, UT, United States
Products
GE OEC Brivo 715 Prime Mobile C-Arm X-Ray Product Used for general surgical applications and musculoskeletal procedures to visualize.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0840-2015Don't want to check this manually?
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