Events

Rappel de Segmented Cervix Applicator

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 Varian Medical Systems, 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
    63667
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0607-2013
  • Date de publication de l'événement
    2012-12-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-04-02
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114525
  • 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
    System, Applicator, Radionuclide, Remote-controlled - Product Code JAQ
  • Cause
    The guide tube which is part of the segmented cervix applicator set is difficult to disconnect from cervical sleeve.
  • Action
    The firm, Varian Medical Systems, sent an "URGENT MEDICAL DEVICE CORRECTION - URGENT FIELD SAFETY NOTICE" letter dated September 28, 2012 to all affected consignees/Customers. The letter identified the affected product, description of problem and recommended user actions to be taken. The consignees/customers were instructed to immediately remove all affected guiding tubes from clinical use, and sequester the components for pending return to Varian Brachy Therapy. Consignees/Customers were requested to complete the attached proof of notification form and return it to Varian Medical Systems. For questions contact-AT&T; international direct dialing network (http://www.business.att.com/bt/dial_guide.isp. Then after hearing the AT&T; signature noise, and. "Please enter the number you are calling", dial 800-360-7909; UK:+44 1293-601-327 or US:+1-434-979-1540. To submit a support request or general inquiry, compose an email with a blank subject line to: brachyhelp@varian.com.

Device

Segmented Cervix Applicator
  • Modèle / numéro de série
    Lot L33, Serial numbers H64Y009-GM, H64A056, H640576, H600272, H640784, H640774, H640764, H600603, H640547.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - U.S. state of Georgia and the countries of Canada, Germany, India, Poland, and Thailand.
  • Description du dispositif
    Segmented Cervix Applicator Set, part number GM11004310, a component used with the tube for segments and cervical sleeves || The guide tube for segments and cervical sleeves in the Segmented Cervix Applicator Set was developed to treat cancer of the cervix, vagina, endometrium, vaginal stump and uterus. It is used for Brachytherapy.
  • Manufacturer
    Varian Medical Systems, Inc.

Manufacturer

Varian Medical Systems, Inc.
  • Adresse du fabricant
    Varian Medical Systems, Inc., 700 Harris St Ste 109, Charlottesville VA 22903-4584
  • Société-mère du fabricant (2017)
    Varian Medical Systems Inc
  • Source
    USFDA