Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2412 ( 2 x 12 channel)
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- QiG Group LLC
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2412 ( 2 x 12 channel)
Product Codes/Lot Numbers:
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.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1193-2016
Related Recalls
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.
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.