Events

Retiro De Equipo (Recall) de Device Recall QuantumPulse machine

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 VIBE Technologies.

¿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
    49609
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0582-2009
  • Fecha de inicio del evento
    2008-10-01
  • Fecha de publicación del evento
    2009-01-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-05-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73919
  • 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
  • Causa
    Medical device marketed without marketing approval for claims that include strengthening, recharging and removing toxins from cells.
  • Acción
    Customers were notified by letter on September 16, 2008 and were told to discontinue use as a medical device. This letter notification included: 1. A warning label to be placed on the Vibe machine stating that it is not a medical device and should not be used as such; 2. An updated operation manual/users guide containing no medical conditions or human body claims; and 3. A certification to be signed by the user and returned acknowledging receipt of the letter; affixed the warning label; will not promote the Quantum Pulse as a medical device; will remove any medical claims from their website; destroy any Quantum Pulse literature making medical claims and destroy any previous operation manual/user guides. Please contact VIBE Technologies at 800-356-9594 for questions or need assistance in complying with these actions.

Device

Device Recall QuantumPulse machine
  • Modelo / Serial
    All serial numbers.
  • Distribución
    Worldwide Distribution.
  • Descripción del producto
    QuantumPulse machine. Vibe Technologies, Greeley, CO. || The device is used to create light wave frequencies to effect cellular activity.
  • Manufacturer
    VIBE Technologies

Manufacturer

VIBE Technologies
  • Dirección del fabricante
    VIBE Technologies, 2329 W 10th St, Greeley CO 80634-3527
  • Source
    USFDA