GENTLEWAVE REF: FG-002-0001
FDA Recall Z-2162-2020 · Posted None
Recalling FirmSonendo Inc
Recall StatusTerminated
Product CodeELC
Date Initiated2019-10-23
Date Terminated2022-01-20
Product Quantity460 foot pedals
Reason for Recall
The console would continue to run for extended period when the foot pedal was released.
Firm 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 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].
Root Cause
Device Design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.