Medical device recalls Moderate risk

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

Recall date
May 22, 2014
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1638-2015
FDA classification
Class II
Brand / firm
GE OEC Medical Systems, Inc
Sold / distributed
US Distribution to the states of: MD, NC, MT, NJ, UT and NY

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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