Events

Rappel de Varian Head Frame

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
    75296
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0077-2017
  • Date de mise en oeuvre de l'événement
    2016-09-13
  • Date de publication de l'événement
    2016-10-13
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-02-24
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149994
  • 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
    Accelerator, linear, medical - Product Code IYE
  • Cause
    Varian medical systems has received a report that a user was able to easily rotate the head frame posts when attached to the mounting cam on the metal head ring. there was no report of serious injury due to this issue.
  • Action
    Varian Medical Systems sent an Urgent Medical Device Removal letter dated September 14, 2016, to all affected sites. Each site was also contacted by telephone to advice users of the issue and request of return of the head frame posts on September 14 and 15th. Calls enabled Varian to prioritize replacement parts for those with patients scheduled in the immediate future. Recommended User Actions: 1.CEASE USE of the Varian Head Frame Assembly and QUARANTINE the Varian Head Frame Assembly and components. 2.Collect, Clean, Disinfect all Head Frame Posts [PN1008016] if used previously. 3.Contact Varian 1.888.827.4265 for Return Material Authorization number, and return all Head Frame Posts in accordance with instructions provided with the enclosed Recall Return Material Form. We sincerely apologize for any inconvenience and thank you in advance for your cooperation. If you require further clarification, please feel free to contact your local Varian Medical Systems Customer Support District or Regional Manager. This notice has been provided to the appropriate Regulatory Authorities. For further questions, please call (650) 424-6833.

Device

Varian Head Frame
  • Modèle / numéro de série
    All Head Frame Posts and Post kits
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution and Internationally to 1 site in Canada, India and Morocco
  • Description du dispositif
    Varian Head Frame - Model number HHF -ALL Head Frame Posts (PN1008016 ) and Post Kits (PN1008016). || The Varian Head Frame System is for use with a computed tomography scanner to perform imaging for treatment planning and a charged particle accelerator to perform immobilization of the treatment target for stereotactic radiosurgery or radiotherapy treatments on cranial lesions, tumors and conditions where radiation treatment is indicated.
  • Manufacturer
    Varian Medical Systems, Inc.

Manufacturer

Varian Medical Systems, Inc.
  • Adresse du fabricant
    Varian Medical Systems, Inc., 911 Hansen Way, Palo Alto CA 94304-1028
  • Société-mère du fabricant (2017)
    Varian Medical Systems Inc
  • Source
    USFDA