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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 1. FR4A-RCV-A0 US, Serial Numbers: 210426-88, 210426-89, 210426-90, 210426-91, 210426-92, 210426-93; 2. FR4A-RCV-A0 EU, Serial Numbers: 210425-19, 210425-22, 210425-23, 210425-6, 210425-63, 210425-64, 210425-7.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Stimwave Technologies Inc
- Reason for Recall:
- The product contains a non-functional component not referenced in product labeling.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
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.
Product Codes/Lot Numbers:
1. FR4A-RCV-A0 US, Serial Numbers: 210426-88, 210426-89, 210426-90, 210426-91, 210426-92, 210426-93; 2. FR4A-RCV-A0 EU, Serial Numbers: 210425-19, 210425-22, 210425-23, 210425-6, 210425-63, 210425-64, 210425-7.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2933-2020
Related Recalls
The product contains a non-functional component not referenced in product labeling.
The product contains a non-functional component not referenced in product labeling.
The product contains a non-functional component not referenced in product labeling.