BEUDAMED
    FDA Enforcement Class II Terminated

    GENTLEWAVE REF: FG-002-0001

    Recall: Z-2162-2020 · Reported June 3, 2020

    Enforcement

    Recall Number
    Z-2162-2020
    Event ID
    85593
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Sonendo Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 3, 2020
    Initiation Date
    October 23, 2019
    Classification Date
    May 28, 2020
    Termination Date
    January 20, 2022
    Address
    26051 Merit Cir Ste 104, N/A, Laguna Hills, CA, 92653-7008, United States

    Description

    GENTLEWAVE REF: FG-002-0001

    Reason

    The console would continue to run for extended period when the foot pedal was released.

    Code Info

    Foot Pedal, P/N: 102-0186-001 of GENTLEWAVE REF: FG-002-0001 device: Lot#: RI18.00462, RI18.00719, RI18.01283, RI18.01608, RI18.02168, RI18.02608, RI18.02882, RI18.02898, RI18.02899, RI18.03196, RI18.03264, RI18.03700, RI19.00901, RI19.01330

    Distribution

    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.

    Quantity

    460 foot pedals