Drug recall
GENTLEWAVE REF: FG-002-0001
FDA recall event 85593 · Class II · Sonendo Inc
Key facts
| Event ID | 85593 |
|---|---|
| Recall numbers | Z-2162-2020 |
| Recalling firm | Sonendo Inc |
| Product type | Devices |
| Products | GENTLEWAVE REF: FG-002-0001 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The console would continue to run for extended period when the foot pedal was released. |
| Initiation date | Oct 23, 2019 |
| Report date | Jun 3, 2020 |
| Termination date | Jan 20, 2022 |
| City | Laguna Hills |
| State | CA |
| Country | United States |
| FEI number | 3010817521 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: