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U.S. Department of Health and Human Services

Class 2 Device Recall Sonendo GentleWave System

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 Class 2 Device Recall Sonendo GentleWave Systemsee related information
Date Initiated by FirmOctober 14, 2022
Date PostedNovember 14, 2022
Recall Status1 Open3, Classified
Recall NumberZ-0234-2023
Recall Event ID 91045
510(K)NumberK190359 
Product Classification Scaler, ultrasonic - Product Code ELC
ProductGentleWave System Posterior CleanFlow Procedure Instrument with Matrices (Single) REF GW-PST-PI01
Code Information GentleWave System Posterior CleanFlow Procedure Instrument (GW-PST-PI01) UDI-DI Code: 00195893912278 Lot Number: W2022080204R
Recalling Firm/
Manufacturer		 Sonendo Inc
26051 Merit Cir Ste 104
Laguna Hills CA 92653-7008
For Additional Information ContactSteven L. Ziemba
949-667-8151
Manufacturer Reason
for Recall		Procedure Instruments with erroneous unit carton labels.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 10/14/2022, the firm sent an "URGENT PRODUCT ADVISORY NOTICE" Letter via FedEx to customers informing them that there are error in the external labeling on the product carton. Information missing includes: a) The GentleWave brand identification; b) The Sonendo brand identification; c) Information such as: "Manufactured by:" and various ISO informational labeling symbols Customers are instructed: -Complete and return (fax or email) the Customer Acknowledgement Letter. -No other action are required. The product and the labeling on the product pouches inside the cartons is correct and unaffected by this error. The labeling has sufficient information to ensure that all customer can correctly identify different Procedure Instruments prior to use. This Notice is intended to reduce any possible confusion to the customer due to the labeling error. For questions, contact Sonendo Customer Support between 7:00 a.m. to 4:00 p.m. (PST) at 1-844-468-5928 or via email to complaints@sonendo.com
Quantity in Commerce16 instruments
DistributionWorldwide - U.S. Nationwide distribution in the state of OH and the country of Canada.
Total Product Life CycleTPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = ELC
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