Recall Z-1194-2016— QiG Group LLC
Class II · Terminated
Class II FDA medical device recall by QiG Group LLC, initiated 2016-01-26, terminated 2017-04-05. FDA's recall record names no specific 510(k) clearance for this event. Product: Algostim LLC, Algovita External Pulse Generator, Trial Stimulator, Model 3400. 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..
- Recalling firm
- QiG Group LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-01-26
- Terminated
- 2017-04-05
- Firm location
- Blaine, MN, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.