FDANovember 12, 2014device
The Revolution CT is a multi-slice (256 detector row) CT scanner consisting of a gantry, patient table, scanner desktop (operator console), system cabinet, power distribution unit (POU). and interconnecting cables.The system includes image acquisition hardware, image acquisition and reconstructio...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
A required quality control test was not performed during installation associated with the software of the Revolution CT scanner.
What to do
FDA enforcement status: Terminated
Brands named
ge healthcare
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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