StimQ Peripheral Nerve Stimulator System (PNS) Model FR4A-TRL-AO US - 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.
Reported: September 9, 2020 Initiated: July 15, 2020 #Z-2929-2020
Product Description
StimQ Peripheral Nerve Stimulator System (PNS) Model FR4A-TRL-AO US - 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.
Details
- Recalling Firm
- Stimwave Technologies Inc
- Units Affected
- 1550 units
- 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.
- Location
- Pompano Beach, FL
Frequently Asked Questions
What product was recalled? ▼
StimQ Peripheral Nerve Stimulator System (PNS) Model FR4A-TRL-AO US - 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.. Recalled by Stimwave Technologies Inc. Units affected: 1550 units.
Why was this product recalled? ▼
The product contains a non-functional component not referenced in product labeling.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 9, 2020. Severity: Moderate. Recall number: Z-2929-2020.
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