Events

Alerte De Sécurité sur Linear accelerator elekta. Anvisa Registration n ° 80569320007. Models under risk: Digital accelerator Precise, Synergy Platform, Synergy S, Infinity, Axesse.

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 Elekta Medical Systems Comércio e Serviços para Radioterapia Ltda.; Elekta Limited.

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
    1323
  • Date
    2013-11-05
  • 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
    Some digital accelerators have increased the settings of automatic screening of the electron applicator in the field to values ​​greater than the factory defaults. The increase in auto-tracking values ​​against factory defaults is against the company's recommendations and may cause the system to not operate in accordance with IEC standards, particularly with regard to the IEC 60601-2-1 safety standard - the Increased auto-tracking values ​​over factory defaults will result in an increase in radiation leakage from the electron applicator in the patient plane as well as around the applicator, which may cause the leakage values ​​to exceed the limits specified in safety standard IEC 60601-2-1. See also the Company Safety Notice at: http://portal.anvisa.gov.br/wps/wcm/connect/0e2b5b8041bb1969933dd79d63c1a945/Aviso_de_Seguranca.pdf?MOD=AJPERES
  • Cause
    Some digital accelerators have increased the settings of automatic screening of the electron applicator in the field to values ​​greater than the factory defaults.
  • Action
    Update of the instructions for use. The company Elekta is announcing to its clients the Important Notice of Field Security, available at: http://portal.anvisa.gov.br/wps/wcm/connect/0e2b5b8041bb1969933dd79d63c1a945/Aviso_de_Seguranca.pdf?MOD=AJPERES

Device

Linear accelerator elekta. Anvisa Registration n ° 80569320007. Models under risk: Digital accele...

Manufacturer

Elekta Medical Systems Comércio e Serviços para Radioterapia Ltda.; Elekta Limited
  • Société-mère du fabricant (2017)
    Elekta AB
  • Source
    ANVSANVISA