QiG Group LLC: Medical Device Recall in 2016 - (Recall #: Z-1194-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: January 26, 2016

Date Posted: March 30, 2016

Recall Number: Z-1194-2016

Event ID: 73150

Reason for Recall:

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.

Status: Terminated

Product Quantity: 31

Code Information:

Serial Numbers: 01DC94, 01DC98, 01DC9B, 01DCA6, 01DCB2, 01DCB3, 01DCB4, 01DCB5, 01DCB6, 01DCB

Distribution Pattern:

Distributed in Germany and Luxembourg.

Voluntary or Mandated:

Voluntary: Firm initiated