QiG Group LLC recalls Algostim LLC, Algovita External Pulse Generator, Trial Stimulator, Model 3400

Recall date

January 26, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1194-2016

FDA classification

Class II

Brand / firm

QiG Group LLC

Sold / distributed

Distributed in Germany and Luxembourg.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Algostim LLC, Algovita External Pulse Generator, Trial Stimulator, Model 3400