FDA-Device2016-03-30Class II
Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2408 ( 3 x 8 channel)
QiG Group LLC
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.
Sold states
Distributed in Germany and Luxembourg.
Affected count
40
Manufactured in
10675 Naples St NE, N/A, Blaine, MN, United States
Products
Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2408 ( 3 x 8 channel)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1192-2016Don't want to check this manually?
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