FDA Device recall Z-1193-2016
Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2412 ( 2 x 12 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 2412 ( 2 x 12 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-1193-2016 |
| 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 2412 ( 2 x 12 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: 03EDB5, 03EDD9, 03EDDA, 03EDDB, 03EDDD, 03EDE0, 03EDE4, 03EDF5, 03EDF6, 03EDFA, 03EDFC, 03EDFF, 03EE07…Serial Numbers: 03EDB5, 03EDD9, 03EDDA, 03EDDB, 03EDDD, 03EDE0, 03EDE4, 03EDF5, 03EDF6, 03EDFA, 03EDFC, 03EDFF, 03EE07, 03EE08, 03EE0A, 03EE0D, 03EE0E, 03EE12, 03EE13, 03EE1A, 03EE30, 03EE3C, 03EE3F, 03EE44, 03EE48, 03EE4C, 03EE4D, 03EE6D, 03EE74, 03EE82, 03EE88, 03EE89, 03EE8F, 03EE94. |
|---|
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-1193-2016%22
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