FDAJanuary 26, 2016device
Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2412 ( 2 x 12 channel)
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Terminated
Brands named
qig
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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