FDA Device recall Z-1192-2016
Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2408 ( 3 x 8 channel)
- FDA Device
- Class II
- terminated
- Published 2016-03-30
On 2016-03-30 the FDA classified a Class II recall of Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2408 ( 3 x 8 channel) 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-1192-2016 |
| 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 Implanted Pulse Generator stimulator, Model 2408 ( 3 x 8 channel)
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: 03EDBF, 03EDC1, 03EDC5, 03EDC7, 03EDC9, 03EDCA, 03EDCE, 03EDD0, 03EDE5, 03EDE8, 03EDE9, 03EDEA, 03EDEF…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, 03EE36, 03EE37, 03EE3A, 03EE3B, 03EE5A, 03EE5B, 03EE60, 03EE96, 03EE97, 03EE98, 03EE9D, 03EE9F, 03EEA2, 03EEA3, 03EEA4, 03EEAC. |
|---|
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-1192-2016%22
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