Device product

GE OEC Brivo 865 plus, Mobile X-ray system laser aimer assemblies (part number 520002DW)

Z-1638-2015

May 22, 2014

Class II

Product summary

Firm: GE OEC Medical Systems, Inc
Event: Event 71298
Status: Terminated
Classification: Class II
Quantity: 9
Official record key: device-enforcement:Z-1638-2015

Official wording

Reason: 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.

Code information: OEC Brivo 865 Plus serial numbers B4S13061, B4S14006, B4S14007, B4S13033, B4S13032, B4S13038, B4S13039, B4S13024, AND B4S13023.

Distribution pattern: US Distribution to the states of: MD, NC, MT, NJ, UT and NY

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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.