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Recall Observatory FDA recall evidence

Device product

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

Z-1194-2016

January 26, 2016

Class II

Product summary

Firm
QiG Group LLC
Event
Event 73150
Status
Terminated
Classification
Class II
Quantity
31
Official record key
device-enforcement:Z-1194-2016

Official wording

Reason: 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.

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

Distribution pattern: Distributed in Germany and Luxembourg.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.