FDASeptember 23, 2016device
OEC Brivo 715 Prime, OEC Brivo 785 Essential, OEC Brivo 865 Advance Product Usage: The OEC Brivo Mobile C-Arm X-Ray Products are designed to provide digital spot film imaging and fluoroscopic image guidance for all adult and pediatric populations for orientations between patient anatomy and surgi...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
GE Healthcare Surgery announces a voluntary field action for the OEC Brivo 715 Prime, OEC Brivo 685 Essential, and OEC Brivo 865 Advance because the circuit board that controls vertical motion of the C-arm may fail, resulting in the C-Arm moving up or down without command.
What to do
FDA enforcement status: Terminated
Brands named
ge oec medical systems
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDAOctopus Evolution Tissue Stabilizer, Model TS20002026-05-12
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