[Recalled] 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 u
The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.
Recall details
| Product | 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 |
|---|---|
| Brand / manufacturer | Stimwave Technologies Inc |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-2931-2020 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 15 July 2020 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: The product contains a non-functional component not referenced in product labeling.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Stimwave Technologies Inc
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.