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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