Events

Alerta De Seguridad para Trade Name: DIGITAL ARTISTE LINEAR ACCELERATOR. ANVISA registration No. 10234230172. Risk class III. List of lots / series: 10587; 10852.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Siemens Healthcare Diagnósticos S.A Endereço; 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
    1888
  • Fecha
    2016-04-20
  • 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
    Recommendation to users and patients: Add a manual pause between the treatment fields if you want the system to stop / pause the treatment to move the table and the gantry manually.
  • Causa
    Siemens healthcare diagnostics sa has identified a problem due to the change of syngo rt therapist software in combination with the isocentric table rotations. there are two situations where the problem may occur: situation 1: when the "automatic movement" is configured a certain message will not be displayed, no pause will be added resulting in the automatic movement of all the programmed positions. situation 2: when "manual movement" is configured, the pause will not be added automatically and in this case the gantry can move before the table movement is performed.
  • Acción
    The Siemens-initiated field action code TH001 / 16 / S deals with a Risk Letter III Customer Submission (situation in which there is a low probability that the use or exposure to a health product may have adverse health consequences ). Recommendation to users and patients: Add a manual pause between the treatment fields if you want the system to stop / pause the treatment to move the table and the gantry manually.

Device

Trade Name: DIGITAL ARTISTE LINEAR ACCELERATOR. ANVISA registration No. 10234230172. Risk class I...

Manufacturer

Siemens Healthcare Diagnósticos S.A Endereço; Siemens Medical Solutions USA Inc.
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    ANVSANVISA