Recall Z-2162-2020 ยท ELC Scaler, Ultrasonic
Sonendo Inc
GENTLEWAVE REF: FG-002-0001
| Date | Oct 23, 2019 |
| Status | Terminated |
| Reason | The console would continue to run for extended period when the foot pedal was released. |
| Root cause | 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 fo |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K190359 | Sonendo GentleWave System Sonendo, Inc., Mar 16, 2019 |