Reported Jun 3, 2020 · Terminated
GENTLEWAVE REF: FG-002-0001
Sonendo Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sonendo Inc · 26051 Merit Cir Ste 104 · Laguna Hills, CA · 92653-7008
Is this the product you have?
- GENTLEWAVE REFFG-002-0001
- Lot codes and dates
- Foot Pedal
- P/N102-0186-001
- of GENTLEWAVE REFFG-002-0001
- device
Lot#: RI18.00462RI18.00719RI18.01283RI18.01608RI18.02168RI18.02608RI18.02882RI18.02898RI18.02899RI18.03196RI18.03264RI18.03700RI19.00901RI19.01330
- Amount recalled
- 460 foot pedals
Where it was sold
Why it was recalled
The console would continue to run for extended period when the foot pedal was released.
This product could cause temporary or reversible health problems — stop using it.
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