SpineSix consists of a motorized treatment table that is controlled by an integral computer. The system is operated by means of 12-inch Color LCD touch screen that displays treatment time, positioning and magnitude and direction of motion. There are eight fully customizable Patient Protocol settings for commonly used treatment settings. The SpineSix BioMotion Spinal System is intended to reproduce normal spine mechanics and physiological movements so that a patient can comfortably and safely experience functional range of motion in a non-weight-bearing environment.
Class I - DangerousWhat Should You Do?
- Check if you have this product: serial numbers: 1001 through 1054
- 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:
- BioMotion Medical Systems, LLC
- Reason for Recall:
- BioMotion is issuing a field correction for all models of the SpineSix (SpineSix01 and SpineSix02; serial numbers 1001 through 1054) to rectify all regulatory deficiencies involving the former owners of the SpineSix product and concurrently preparing the submission of a 510(k) application in order to receive premarket clearance for SpineSix.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
SpineSix consists of a motorized treatment table that is controlled by an integral computer. The system is operated by means of 12-inch Color LCD touch screen that displays treatment time, positioning and magnitude and direction of motion. There are eight fully customizable Patient Protocol settings for commonly used treatment settings. The SpineSix BioMotion Spinal System is intended to reproduce normal spine mechanics and physiological movements so that a patient can comfortably and safely experience functional range of motion in a non-weight-bearing environment.
Product Codes/Lot Numbers:
serial numbers: 1001 through 1054
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0571-2013