Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2408 ( 3 x 8 channel)
Class I - DangerousWhat Should You Do?
- Check if you have this product: Serial Numbers: 03EDBF, 03EDC1, 03EDC5, 03EDC7, 03EDC9, 03EDCA, 03EDCE, 03EDD0, 03EDE5, 03EDE8, 03EDE9, 03EDEA, 03EDEF, 03EDF0, 03EE01, 03EE03, 03EE05, 03EE1C, 03EE1F, 03EE24, 03EE25, 03EE26, 03EE28, 03EE34, 03EE35, 03EE36, 03EE37, 03EE3A, 03EE3B, 03EE5A, 03EE5B, 03EE60, 03EE96, 03EE97, 03EE98, 03EE9D, 03EE9F, 03EEA2, 03EEA3, 03EEA4, 03EEAC.
- 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 2408 ( 3 x 8 channel)
Product Codes/Lot Numbers:
Serial Numbers: 03EDBF, 03EDC1, 03EDC5, 03EDC7, 03EDC9, 03EDCA, 03EDCE, 03EDD0, 03EDE5, 03EDE8, 03EDE9, 03EDEA, 03EDEF, 03EDF0, 03EE01, 03EE03, 03EE05, 03EE1C, 03EE1F, 03EE24, 03EE25, 03EE26, 03EE28, 03EE34, 03EE35, 03EE36, 03EE37, 03EE3A, 03EE3B, 03EE5A, 03EE5B, 03EE60, 03EE96, 03EE97, 03EE98, 03EE9D, 03EE9F, 03EEA2, 03EEA3, 03EEA4, 03EEAC.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1192-2016
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.