FDA recall Z-2162-2020

Product

GENTLEWAVE REF: FG-002-0001

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.

Key facts

Status

Terminated

Initiation date

2019-10-23

Report date

2020-06-03

Termination date

2022-01-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Laguna Hills, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2162-2020