Drug recall
Algostim LLC, Algovita External Pulse Generator, Trial Stimulator, Model 3400
FDA recall event 73150 · Class II · QiG Group LLC
Key facts
| Event ID | 73150 |
|---|---|
| Recall numbers | Z-1192-2016, Z-1193-2016, Z-1194-2016 |
| Recalling firm | QiG Group LLC |
| Product type | Devices |
| Products | Algostim LLC, Algovita External Pulse Generator, Trial Stimulator, Model 3400, Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2408 ( 3 x 8 channel), Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2412 ( 2 x 12 channel) |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The implantable pulse generator (IPG) model 2408 had suboptimal performance establishing a connection to the external devices unless they were brought into close proximity (as close as 5 cm). The… |
| Initiation date | Jan 26, 2016 |
| Report date | Mar 30, 2016 |
| Termination date | Apr 5, 2017 |
| City | Blaine |
| State | MN |
| Country | United States |
| FEI number | 3010109865 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: