Events

Alerta De Seguridad para LINEAR DIGITAL ARTISTE CELERATOR - 10234230172 - Risk class III. Serial Numbers: 10514 (Artiste syngo RT Therapist model) and 10321 (Artiste syngo RT Oncologist model).

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
    1773
  • Fecha
    2015-12-18
  • 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
    The company Siemens informs that it is working to find a software solution to properly solve the problem described in the TH011 / 15 / S field action. Once the solution is available, the systems identified will be updated as soon as possible.
  • Causa
    The company reports a possible patient-related safety issue when using the adaptive targeting option in the syngo rt therapist and the syngo rt oncologist (versions 4.3.138, 4.3.Sp1, 4.3.1_ar1 or 4.3.1_mr2 ) in combination with multiple isocenters based on a planning ct. the described problem occurs if one or more treatment plans with at least 2 isocenters based on a planning ct are used and when a conical beam ct was acquired for each isocenter. the system supports the workflow correctly until the user makes a manual change to another isocenter. at this time, the overlapping images in adaptive targeting may be incorrect.
  • Acción
    The company recommends users and patients: Always use automatic registration after a manual change to another isocenter before using manual registration. Therefore, for all security measures, all affected customers should implement this recommendation and immediately inform all persons who may be involved in such a question. (Field Action Code TH011 / 15 / S)

Device

LINEAR DIGITAL ARTISTE CELERATOR - 10234230172 - Risk class III. Serial Numbers: 10514 (Artiste s...

Manufacturer

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