FDA-Device2015-06-17Class II
GE OEC Brivo 865 plus, Mobile X-ray system laser aimer assemblies (part number 520002DW)
GE OEC Medical Systems, Inc
Hazard
Laser aimer assemblies were shipped without certification of the overall assembly or submitting a laser product report and therefore do not comply with the US regulations for laser products.
Sold states
US Distribution to the states of: MD, NC, MT, NJ, UT and NY
Affected count
9
Manufactured in
384 N Wright Brothers Dr, N/A, Salt Lake City, UT, United States
Products
GE OEC Brivo 865 plus, Mobile X-ray system laser aimer assemblies (part number 520002DW)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1638-2015Don't want to check this manually?
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