QiG Group Recalls
3 recalls on record · March 30, 2016 to March 30, 2016 · Medical Devices
March 30, 2016Medical DevicesFDA
QiG Group LLC recalls Algostim LLC, Algovita External Pulse Generator, Trial Stimulator, Model 3400
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.
March 30, 2016Medical DevicesFDA
QiG Group LLC recalls Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2412 ( 2 x 12 channel)
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.
March 30, 2016Medical DevicesFDA
QiG Group LLC recalls Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2408 ( 3 x 8 channel)
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.