FDAOctober 23, 2019device
GENTLEWAVE REF: FG-002-0001
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The console would continue to run for extended period when the foot pedal was released.
What to do
FDA enforcement status: Terminated
Brands named
sonendo
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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