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U.S. Department of Health and Human Services

Class 2 Device Recall GentleWave System

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  Class 2 Device Recall GentleWave System see related information
Date Initiated by Firm October 23, 2019
Create Date May 28, 2020
Recall Status1 Terminated 3 on January 20, 2022
Recall Number Z-2162-2020
Recall Event ID 85593
510(K)Number K190359  
Product Classification Scaler, ultrasonic - Product Code ELC
Product GENTLEWAVE REF: FG-002-0001
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 
Recalling Firm/
Manufacturer
Sonendo Inc
26051 Merit Cir Ste 104
Laguna Hills CA 92653-7008
For Additional Information Contact Jacqueline Collins
949-766-3636 Ext. 8033
Manufacturer Reason
for Recall
The console would continue to run for extended period when the foot pedal was released.
FDA Determined
Cause 2
Device Design
Action On 10/23/2019, "Urgent: Medical Device Recall" of a foot pedal, the firm provided information on how to recognize the device malfunction as: If the treatment fluid is continuously cycling after the foot pedal is released, this is a sign that the foot pedal is not working properly. The firm instructed customers to replace the current foot pedal with the new foot pedal that was sent with this notification. and instructed to: Attach the new foot pedal to the Foot Pedal connection located at the lower rear of the Console as instructed per IFU. The firm instructed customers to return the current foot pedal in the provided pre-paid FedEx box and send the enclosed acknowledgement letter to the firm by mail. The contact information was provided to customers as: Calls Monday through Friday 5:00 AM to 5:00 PM (Pacific Time) 1-844-468-5928 or email complaints@sonendo.com.
Quantity in Commerce 460 foot pedals
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = ELC and Original Applicant = Sonendo, Inc.
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