Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2408 ( 3 x 8 channel)
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1192-2016.
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.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1192-2016.
Recall terminated by FDA.
✅ What you should do
- Stop using the product if you own it.
- Check the model number, lot code, or sell-by date against the recall notice above.
- Contact Qig Group Llc or the retailer where you bought it for a refund, replacement, or repair.
- For the most current official instructions, visit the FDA recall page.
- If you've been hurt by this product, report the incident to FDA.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1192-2016.
QiG Group LLC
About the U.S. Food and Drug Administration
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Qig Group Llc Recall FAQ
Qig Group Llc is the subject of a medical implants safety report: Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2408 ( 3 x 8 channel). The notice was published on January 26, 2016 by the U.S. Food and Drug Administration (FDA). Approximately 40 units are potentially affected.