FDA recall Z-0233-2023

Sonendo Inc · Class II · device

Product

GentleWave System APM Procedure Instrument with Matrix REF GW-APM-PI02

Reason for recall

Procedure Instruments with erroneous unit carton labels.

Distribution

Worldwide - U.S. Nationwide distribution in the state of OH and the country of Canada.

Key facts

Status: Ongoing
Initiation date: 2022-10-14
Report date: 2022-11-23
Voluntary/Mandated: Voluntary: Firm initiated
Location: Laguna Hills, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0233-2023