Medical DeviceJun 3, 2020
Sonendo GENTLEWAVE REF: FG-002-0001 recall — FDA Z-2162-2020
The console would continue to run for extended period when the foot pedal was released.
Class IIFDA: TerminatedSonendo Inc.
Recall history in this database
Classification mix: Class II: 1.
Understanding this recall history
This page summarizes recall records in which the official source identifies Sonendo Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.