Events

Alerte De Sécurité sur RADIOTERAPIC LINEAR ACCELERATORS MODELS: CLINAC HIGH ENERGY, LOW ENERGY, CX, iX, UNIQUE and TRILOGY. Anvisa Registry: 10405410001, 10405410010, 10405410011, 10405410012 and 10405410017.

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..

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
    1240
  • Date
    2013-03-04
  • 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
    Varian is sending a "Warning Caution" letter to users of their linear radiotherapy accelerators, alerting them to the importance of monitoring and maintaining the performance of such equipment - operating equipment that is malfunctioning can cause serious injury or death. For additional information, please refer to the Caution Notice issued by the company at http://portal.anvisa.gov.br/wps/wcm/connect/9b70d9804f23a512b85abcc88f4b6a31/Aviso_de_Precaucao_Varian.PDF?MOD=AJPERES.
  • Cause
    Caution notice from the manufacturer regarding the monitoring and maintenance of linear accelerator performance.
  • Action
    Varian advises users to: a) follow the guidelines provided in the user manuals for the linear accelerators of the models cited in this alert; b) notify all persons in the radiotherapy department of the contents of the letter (Warning of Caution) sent by the company; c) attach a copy of said letter in the user manuals of the respective equipment.

Device

RADIOTERAPIC LINEAR ACCELERATORS MODELS: CLINAC HIGH ENERGY, LOW ENERGY, CX, iX, UNIQUE and TRILO...

Manufacturer

VARIAN MEDICAL SYSTEMS BRASIL LTDA.