Events

Retiro De Equipo (Recall) de Device Recall SpineSix01/SpineSix02

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por BioMotion Medical Systems, LLC.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    63788
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0571-2013
  • Fecha de inicio del evento
    2012-11-12
  • Fecha de publicación del evento
    2012-12-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-11-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114771
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Exerciser, powered - Product Code BXB
  • Causa
    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.
  • Acción
    BioMotion issued a field correction letter dated October 18, 2012 for all models of the SpineSix (SpineSix01 and SpineSix02; serial numbers 1001 through 1054) to all affected customers. The letter identified the product, problem, and actions to be taken. BioMotion is preparing the submission of a 510(k) application in order to receive premarket clearance for SpineSix. Contact the firm at 772-405-7899 for questions concerning this letter.

Device

Device Recall SpineSix01/SpineSix02
  • Modelo / Serial
    serial numbers: 1001 through 1054
  • Clasificación del producto
    Physical Medicine Devices
  • 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
    BioMotion Medical Systems, LLC

Manufacturer

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