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Recall Observatory FDA recall evidence

Device product

GENTLEWAVE REF: FG-002-0001

Z-2162-2020

October 23, 2019

Class II

Product summary

Firm
Sonendo Inc
Event
Event 85593
Status
Terminated
Classification
Class II
Quantity
460 foot pedals
Official record key
device-enforcement:Z-2162-2020

Official wording

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

Code information: 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 pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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