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Sonendo Inc recalls GENTLEWAVE REF: FG-002-0001
Recalled June 3, 2020 · FDA recall Z-2162-2020 · Sonendo
Hazard
The console would continue to run for extended period when the foot pedal was released. · FDA Class II
Units
460 foot pedals
Sold at
U.S.: OR, CA, NY, SD, CO, AL, WA, IN, TX, NM, IL, NC, AZ, TN, KS, MT, FL, UT, OK, ID, OH, ME, WV, CT, GA, MO, MI, NE, KY, VT, ND, NJ, DC, LA, NY, MA, VA, MN, SC, MD, PA, NH, NV, NE, OR, MS, WI, AK, IA. No foreign consignees.
Description
The console would continue to run for extended period when the foot pedal was released.
Product
GENTLEWAVE REF: FG-002-0001
Manufacturer(s)
Sonendo Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →