Events

Alerte De Sécurité sur HIGH ENERGY RADIOTHERAPIC LINEAR ACCELERATOR CLINAC. Models: 21EX, 23EX, 2100C, 2100C / D, 2300C / D, iX, CX, NOVALIS, Tx, TRILOGY, TRILOGY TX. Anvisa Registry: 10405410010, 10405410016, 10405410017, 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 INC; Varian Medical Systems Brasil..

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
    1410
  • Date
    2014-08-11
  • 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
    The action recommended by the manufacturer is palliative and the company informed that a software fix is ​​being developed, but has not determined the deadline for its completion. See details of the field action in the Varian alert message, available at http://portal.anvisa.gov.br/wps/wcm/connect/09468c004510a13a938db7c2afb947e8/Messagem+de+Alerta.pdf?MOD=AJPERES #### Update (10/16/2014): The company reported that the field correction is planned for October 2015. #### Updated 10/25/2017, the company submitted a monitoring report informing the recommendation in the notice of security check of the dosimetry symmetry of the equipment with an extra security system called Yield Interlock, registration 10405410032.
  • Cause
    Unexpected downward trend in beam output on linear accelerators c-series [he] for 6mv, when the photon treatment mode is activated.
  • Action
    Users should implement a daily verification of the constancy of the output rate of the photon beams, as recommended. It is important that these daily checks include all 6MV [6SRS, 6FFF and 6X] beams. Users should be aware of any sudden decrease in dose output greater than or equal to 3% per day or greater or equal to 6% per week. See detailed information at http://portal.anvisa.gov.br/wps/wcm/connect/09468c004510a13a938db7c2afb947e8/Messagem+de+Alerta.pdf?MOD=AJPERES

Device

HIGH ENERGY RADIOTHERAPIC LINEAR ACCELERATOR CLINAC. Models: 21EX, 23EX, 2100C, 2100C / D, 2300C ...

Manufacturer

Varian Medical Systems INC; Varian Medical Systems Brasil.