Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1192-2016 — Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2408 ( 3 x 8 channel)

U.S. FDA — Device Enforcement · United States · 2016-01-26 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1192-2016
Date of alert
2016-01-26
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
QiG Group LLC
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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