Events

Rappel de Device Recall VIBE

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par VIBE Technologies.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    49590
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-0201-2009
  • Date de mise en oeuvre de l'événement
    2008-10-01
  • Date de publication de l'événement
    2008-11-03
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-05-21
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73858
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    Medical device marketed without marketing approval for claims that include cures cancer, infections, depression.
  • Action
    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
  • Modèle / numéro de série
    All serial numbers
  • Distribution
    Worldwide
  • Description du dispositif
    Vibe Technologies, VIBE machine, Vibrational Integrated Biophotonic Energizer.
  • Manufacturer
    VIBE Technologies

Manufacturer

VIBE Technologies
  • Adresse du fabricant
    VIBE Technologies, 2329 W 10th St, Greeley CO 80634-3527
  • Source
    USFDA