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QiG Group LLC recalls Algostim LLC, Algovita External Pulse Generator, Trial Stimulator, Model 3400
Recalled March 30, 2016 · FDA recall Z-1194-2016 · QiG Group
Hazard
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. · FDA Class II
Units
31
Sold at
Distributed in Germany and Luxembourg.
Description
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.
Product
Algostim LLC, Algovita External Pulse Generator, Trial Stimulator, Model 3400
Manufacturer(s)
QiG Group LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →