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FDAJanuary 21, 2020device

Selenia Dimensions Mammography System, Model number ASY-04160, Selenia Dimensions Gantry, UDI 15420045505636,

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

The recalling firm has received reports from the field of the C-arm on the Selenia Dimensions system seizing or dropping during field repairs and cleaning of the systems.

What to do

FDA enforcement status: Terminated

Brands named

hologic

UPCs

810021431758100214317681002143177810031431788100314317981003143180810031431818100314318281003143183810031431848100314318581003143186

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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