FDA Device recall Z-1194-2016
Algostim LLC, Algovita External Pulse Generator, Trial Stimulator, Model 3400
- FDA Device
- Class II
- terminated
- Published 2016-03-30
On 2016-03-30 the FDA classified a Class II recall of Algostim LLC, Algovita External Pulse Generator, Trial Stimulator, Model 3400 by Qig Group, citing 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 clo….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1194-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-01-26 |
| Published | 2016-03-30 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Qig Group |
| Distribution | n/a |
Product
Algostim LLC, Algovita External Pulse Generator, Trial Stimulator, Model 3400
Reason
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.
Identifiers
| code_info | Serial Numbers: 01DC94, 01DC98, 01DC9B, 01DCA6, 01DCB2, 01DCB3, 01DCB4, 01DCB5, 01DCB6, 01DCB |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1194-2016%22
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