Events

Alerta De Seguridad para LINEAR DIGITAL ARTISTE ACCELERATOR, Registration 10234230172 - Serial Number: 100041.

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
    1677
  • Fecha
    2015-08-27
  • 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
    If the dose or the time of treatment is affected, the patient may receive an excessive dose and the consequences may be lethal. If a geometric parameter is affected (field size, depth, angle) there may be a geometric error and the target may receive a lower than recommended dose, while normal structures may receive an excessive dose. This can result in serious health consequences. However, Siemens notes that the error described by the manufacturer ELEKTA has not been observed with systems installed and configured in accordance with the Siemens procedure. Therefore, unless the system configuration has been changed or acquired additional modules after delivery of the system by Siemens, the system should not be affected by the problem described by the ELEKTA manufacturer.
  • Causa
    Mosaiq software maker, elekta, has identified a problem in mosaiq, related to the windows operating system and mosaiq configurations, which results in displaying incorrect decimal symbols and / or unintentional modification of numeric data that are 10 (multiplication by 10, 100, 1000, etc.). there may also be inconsistencies in date and time formats. this problem occurs when an optional language override parameter is set in mosaiq and the language you have has a different decimal symbol than the one defined in the windows control panel settings for region and language. for example, a user may wish to select their native language (german) for text, but keep the windows operating system in english (so, in this case, all numerical data should behave according to the settings from windows to english) ). most areas of mosaiq can correctly read the windows region formats; however, some other areas treat the language overlay as a general locale overlay, which affects numeric, date, and time formats. that is the source of the problem. language overlay should not overlap numeric, date, and time formats in any case. the problem can be avoided by not selecting the "runtime language" override option.
  • Acción
    The company guides you to verify that the optional language replacement parameter is set in MOSAIQ and recommends contacting Siemens Healthcare for assistance.

Device

LINEAR DIGITAL ARTISTE ACCELERATOR, Registration 10234230172 - Serial Number: 100041.

Manufacturer

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