Events

Alerte De Sécurité sur Clinical Radiotherapy Linear Accelerator with 4DITC - version 10 and 11. Models at risk: Clinac 6EX, Clinac 600C, Clinac IX, Clinac 23EX and Trilogy. Corresponding Anvisa records: 10405410001, 10405410010, 10405410011 and 10405410012.

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Varian Medical Systems Brasil Ltda.; Varian Medical Systems Inc.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    1444
  • Date
    2014-10-23
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • Notes supplémentaires dans les données
    Sending consecutive ExactTrac signals to the 4D Intgrated Treatment Console may cause unexpected deletion of both the ExactTrac interlocks and the BCCV from the equipment. In the occurrence of the described problem, it is possible to irradiate the patient using a cone different from that specified by the treatment planning, since the BCCV check has not been completed. Varian received no notification of injury to the patient related to the problem. See additional information at http://portal.anvisa.gov.br/wps/wcm/connect/8179950045f00258a0d6a47ffa9843d8/Aviso+Urgente+de+Seguran%C3%A7a.pdf?MOD=AJPERES.
  • Cause
    Unexpected device authorization.
  • Action
    The company initiated the communication to the customers and plans to carry out the correction in the field (software update) of the equipment at a date not yet determined.

Device

Clinical Radiotherapy Linear Accelerator with 4DITC - version 10 and 11. Models at risk: Clinac 6...

Manufacturer

Varian Medical Systems Brasil Ltda.; Varian Medical Systems Inc