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GE OEC Medical Systems, Inc recalls GE OEC Brivo 865 plus, Mobile X-ray system laser aimer assemblies (part number 520002DW)
Recalled June 17, 2015 · FDA recall Z-1638-2015 · GE OEC Medical Systems
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. · FDA Class II
Units
9
Sold at
US Distribution to the states of: MD, NC, MT, NJ, UT and NY
Description
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.
Product
GE OEC Brivo 865 plus, Mobile X-ray system laser aimer assemblies (part number 520002DW)
Manufacturer(s)
GE OEC Medical Systems, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →