Events

Alerta De Seguridad para LINEAR DIGITAL ARTISTE ACCELERATOR, Registration 10234230172 - Serial Numbers: 10233; 10321.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Siemens Ltda.; Siemens AG; Siemens Medical Solutions USA, Inc..

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    1678
  • Fecha
    2015-08-26
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Siemens Ltda informs that the application of an incorrect deviation to the patient's position may result in undue treatment in terms of dose administration at the wrong location.
  • Causa
    Siemens has identified that by using the adaptive targeting option in the syngo rt therapist 4.3.Sp1 in combination with images acquired with ctvision, an incorrect deviation calculation may occur. applying an incorrect deviation to the patient's position may result in undue treatment of the patient in terms of dose administration at the wrong site.
  • Acción
    The company performed the software update (new software syngo RT OncologistTM). It also states that the software update corrects this behavior and recommends attaching the security note to the User's Guide, chapter "Security Information Cards". For more information, see Appendix Letter to the customer and through the company service center.

Device

LINEAR DIGITAL ARTISTE ACCELERATOR, Registration 10234230172 - Serial Numbers: 10233; 10321.

Manufacturer

Siemens Ltda.; Siemens AG; Siemens Medical Solutions USA, Inc.
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    ANVSANVISA