GENTLEWAVE REF: FG-002-0001
Recall
- Recall Number
- Z-2162-2020
- Event Number
- 85593
- Firm
- Sonendo Inc
- FEI Number
- 3010817521
- Product Code
- ELC
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- October 23, 2019
- Terminated
- January 20, 2022
- Address
- 26051 Merit Cir, Ste 104, Laguna Hills, CA, 92653-7008
Description
GENTLEWAVE REF: FG-002-0001
The console would continue to run for extended period when the foot pedal was released.
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 [email protected].
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.
460 foot pedals