Algostim LLC — Class II medical device recall Z-1192-2016
Terminated recall by QiG Group LLC, reported 2016-03-30. The implantable pulse generator (IPG) model 2408 had suboptimal performance establishing a connection to the e
| Recall number | Z-1192-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | QiG Group LLC, Blaine, MN, United States |
| Recall initiated | 2016-01-26 |
| Classified | 2016-03-18 |
| Reported by FDA | 2016-03-30 |
| Terminated | 2017-04-05 |
| Countries outside the US | DE, LU |
| Quantity | 40 |
| Serial numbers | 03EDBF, 03EDC1, 03EDC5, 03EDC7, 03EDC9, 03EDCA, 03EDCE, 03EDD0, 03EDE5, 03EDE8, 03EDE9, 03EDEA, 03EDEF, 03EDF0, 03EE01, 03EE03, 03EE05, 03EE1C, 03EE1F, 03EE24, 03EE25, 03EE26, 03EE28, 03EE34, 03EE35 and 16 more |
| Model numbers | 2408 |
Product
Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2408 ( 3 x 8 channel)
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 following functions may not be available: Reprogramming the stimulator, Adjusting stimulation parameters (on/off, intensity modifications, stimulation program selection), and Recharging the stimulator.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1192-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.