GENTLEWAVE REF: FG-002-0001
- Company
- Sonendo Inc
- Recall Initiated
- October 23, 2019
- Terminated
- January 20, 2022
- Recall Number
- Z-2162-2020
- Quantity
- 460 foot pedals
- Firm Location
- Laguna Hills, CA
Reason for Recall
The console would continue to run for extended period when the foot pedal was released.
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.
Lot / Code Info
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
Root Cause
Device Design
Action Taken
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.