Z-2931-2020 Class II Ongoing
FDA device recall Z-2931-2020 was initiated by Stimwave Technologies Inc on July 15, 2020 and is designated Class II. Reason for recall: The product contains a non-functional component not referenced in product labeling. The recall status is ongoing. Affected quantity: 6 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 9, 2020
- Initiation Date
- July 15, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6 units
Product Description
StimQ Peripheral Nerve Stimulator System (PNS) Models FR4A-SPR-BO 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.
Distribution Pattern
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.
Code Information
FR4A-SPR-BO-US, Serial Numbers: 210431-88, 210431-89, 210431-90, 210431-91, 210431-92, 210431-93;