QiG Group LLC: Medical Device Recall in 2016 - (Recall #: Z-1193-2016)

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 Implanted Pulse Generator stimulator, Model 2412 ( 2 x 12 channel)

Product Classification:

Class II

Date Initiated: January 26, 2016
Date Posted: March 30, 2016
Recall Number: Z-1193-2016
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: 34
Code Information:

Serial Numbers: 03EDB5, 03EDD9, 03EDDA, 03EDDB, 03EDDD, 03EDE0, 03EDE4, 03EDF5, 03EDF6, 03EDFA, 03EDFC, 03EDFF, 03EE07, 03EE08, 03EE0A, 03EE0D, 03EE0E, 03EE12, 03EE13, 03EE1A, 03EE30, 03EE3C, 03EE3F, 03EE44, 03EE48, 03EE4C, 03EE4D, 03EE6D, 03EE74, 03EE82, 03EE88, 03EE89, 03EE8F, 03EE94.

Distribution Pattern:

Distributed in Germany and Luxembourg.

Voluntary or Mandated:

Voluntary: Firm initiated