FDA recall Z-2933-2020

Stimwave Technologies Inc · Class II · device

Product

StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-RCV-AO US and 2. FR4A-RCV-A0 EU - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.

Reason for recall

The product contains a non-functional component not referenced in product labeling.

Distribution

Worldwide distribution - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KY, KS, LA, MD, MO, MI, MN, MA, MS, NC, NM, ND, NV, NY, NE, NJ, OK, OH, OR, PR, PA, RI, SC, TN, TX, UT, VA, WA, WI and the countries of The Netherlands, Belgium, Slovakia, Switzerland, Germany, United Kingdom, Argentina, Italy, Spain, South Africa, Iran, Israel, and Czech Republic.

Key facts

Status
Ongoing
Initiation date
2020-07-15
Report date
2020-09-09
Voluntary/Mandated
Voluntary: Firm initiated
Location
Pompano Beach, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2933-2020