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Stimwave Technologies Inc recalls StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-RCV-AO US and 2. FR4A-RCV-A0 EU - Product Usage: is used
Recalled September 9, 2020 · FDA recall Z-2933-2020 · Stimwave Technologies
Hazard
The product contains a non-functional component not referenced in product labeling. · FDA Class II
Units
13 units
Sold at
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.
Description
The product contains a non-functional component not referenced in product labeling.
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.
Manufacturer(s)
Stimwave Technologies Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →