Device Recall SpineSix01/SpineSix02

  • Modelo / Serial
    serial numbers: 1001 through 1054
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Distributed in Florida, Georgia, Tennessee, New Jersey, New York, Pennsylvania, and Wisconsin.
  • Descripción del producto
    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.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    BioMotion Medical Systems, LLC, 6619 North Scottsdale Rd., scottsdale AZ 85250
  • Source
    USFDA