Z-1194-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 30, 2016
- Initiation Date
- January 26, 2016
- Termination Date
- April 5, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 31
Product Description
Algostim LLC, Algovita External Pulse Generator, Trial Stimulator, Model 3400
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.
Distribution Pattern
Distributed in Germany and Luxembourg.
Code Information
Serial Numbers: 01DC94, 01DC98, 01DC9B, 01DCA6, 01DCB2, 01DCB3, 01DCB4, 01DCB5, 01DCB6, 01DCB