Events

Alerta De Seguridad para FLUOROSCOPIC SYSTEM OF X-RAYS AXIOM Luminos dRF, Registry No. 10234230153. Series numbers affected in Brazil: 1163; 1280; 1287; 1300; 1302; 1303; 1308; 1310; 1311; 2053; 2179; 2181; 2270; 2307; 2308.

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.

¿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
    1730
  • Fecha
    2015-11-04
  • 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 informs that using the automatic exposure control, the maximum exposure time is usually limited to 500 ms. Therefore, this will be the maximum time a patient can be exposed to unintentional radiation. In addition, overexposure of image may occur and thus does not provide good diagnostic quality.
  • Causa
    Siemens healthcare has identified that during an rad examination with automatic exposure control, an unexpected malfunction may result in a longer radiation exposure than is required. this can also result in overexposure of image and not provide good diagnostic quality. as a result, the examination performed will need to be repeated. this malfunction can only occur in auto exposure mode.
  • Acción
    Siemens Healthcare informs that no action can be taken to prevent such malfunction. However, it does not recommend discontinuation of equipment use. Once all necessary material is available for the software update, it is recommended that the identified customers immediately accept the appointment of a Siemens technician visit, so as not to delay the correction that will be carried out in the field.

Device

FLUOROSCOPIC SYSTEM OF X-RAYS AXIOM Luminos dRF, Registry No. 10234230153. Series numbers affecte...

Manufacturer

Siemens Ltda.; Siemens AG
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    ANVSANVISA