Events

Rappel de Device Recall Vycor Medical ViewSite Brain Access System

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 Vycor Medical, Inc..

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
    63319
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-0673-2013
  • Date de mise en oeuvre de l'événement
    2012-08-21
  • Date de publication de l'événement
    2013-01-17
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-05-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113513
  • 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
    Retractor, self-retaining, for neurosurgery - Product Code GZT
  • Cause
    Vycor medical recalled their vbas (vycor viewsite brain access system) because an unidentified black fiber was found on the device.
  • Action
    Vycor Medical, Inc. notified all customers of the product recall by telephone and follow-up letter. Customers were instructed to quarantine affected products and hold the shipment(s) in quarantine unti further notice. The units will be replaced with inspected and passed units. All distributors were instructed to notify their customers of the recall and ask to have them return their stock. For question call 561-558-2020.

Device

Device Recall Vycor Medical ViewSite Brain Access System
  • Modèle / numéro de série
    Model # TC171105 Lot # VM83450
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (Nationwide) in the states of TX, IL, NJ, FL, OH, PA and (International) in the country of Japan.
  • Description du dispositif
    Vycor Medical ViewSite Brain Access System 17mm/ 11mm / 5cm Device***STERILE*** || Product Usage: || The Vycor Viewsite Brain Access System (VBAS) has been designed to serve as a self-retaining retractor system for brain tissue. It is comprised of an introducer and a working channel port that are secured by a spring-loaded latch. Each device allows for the gentle retraction of tissue, visualization of the surgical site and for the smooth manipulation of introduced instruments. The range of device sizes (width and length) provides various working channel sizes.
  • Manufacturer
    Vycor Medical, Inc.

Manufacturer

Vycor Medical, Inc.
  • Adresse du fabricant
    Vycor Medical, Inc., 6401 Congress Ave Ste 140, Boca Raton FL 33487-2841
  • Société-mère du fabricant (2017)
    Vycor Medical, Inc.
  • Source
    USFDA