Recall Z-0234-2023 ยท ELC Scaler, Ultrasonic
Sonendo Inc
GentleWave System Posterior CleanFlow Procedure Instrument with Matrices (Single) REF GW-PST-PI01
| Date | Nov 14, 2022 (initiated Oct 14, 2022) |
| Status | Open, Classified |
| Reason | Procedure Instruments with erroneous unit carton labels. |
| Root cause | Under Investigation by firm |
| Action | On 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 unaff |
| Quantity | 16 instruments |
| Distribution | Worldwide - U.S. Nationwide distribution in the state of OH and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K190359 | Sonendo GentleWave System Sonendo, Inc., Mar 16, 2019 |