Events

Retiro De Equipo (Recall) de Device Recall VIBE

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
    49590
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0201-2009
  • Fecha de inicio del evento
    2008-10-01
  • Fecha de publicación del evento
    2008-11-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-05-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73858
  • 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 cures cancer, infections, depression.
  • Acción
    Vibe Technologies notified their customers by letter on October 1, 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. 3. A certification to be signed by the user and returned acknowledging that they: received the letter; affixed the warning label to the Vibe machine; understand that the Vibe machine does not affect the structure/function of the human or animal body; will not promote the Vibe machine as a medical device; will remove any medical claims from their website; destroy any Vibe literature making medical claims. Approximately three weeks after the certified mailing, the firm will begin performing recall effectiveness checks.

Device

Device Recall VIBE
  • Modelo / Serial
    All serial numbers
  • Distribución
    Worldwide
  • Descripción del producto
    Vibe Technologies, VIBE machine, Vibrational Integrated Biophotonic Energizer.
  • Manufacturer
    VIBE Technologies

Manufacturer

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