Reported Sep 9, 2020 · Ongoing
StimQ Peripheral Nerve Stimulator System (PNS) Models FR4A-SPR-BO US - Product Usage: is used for peripheral neural…
Stimwave Technologies Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Stimwave Technologies Inc · 1310 Park Central Blvd S · Pompano Beach, FL · 33064-2217
Is this the product you have?
- StimQ Peripheral Nerve Stimulator System (PNS)
- Models FR4A-SPR-BO US - Product Usageis 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
- Lot codes and dates
- FR4A-SPR-BO-US
- Serial Numbers
210431-88210431-89210431-90210431-91210431-92210431-93
- Amount recalled
- 6 units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
Why it was recalled
The product contains a non-functional component not referenced in product labeling.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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