Events

Alerta De Seguridad para ADVIA CENTRALINK Technical Name: Software ANVISA Registration Number: 10345161928 Hazard Class: I Affected Model: ADVIA CentraLink Affected serial numbers: DC1733486, DC1740245, DC1689706, 5699N3J, JYKZN3J, 66MDN3J, GBY382J, DC1751283, DC1793356, DC18449841, DC1846667, DC1892717, DC1906259, DC1921198, DC1921200, DC1916941, DC1948495, DC1950630, DC1703782

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.; Siemens Healthcare Diagnostics 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
    2078
  • Fecha
    2016-12-16
  • 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 recommends that the LIS specify the type of sample in the work order. CentraLink software is designed to operate in an environment in which information pertaining to the type of sample is specified in the order that is received from the LIS. The CentraLink configuration will be reviewed. If the LIS does not include information regarding the type of sample in the sample order sent to CentraLink and pre-tests checked against the sample type, the settings will be updated. Siemens does not recommend retroactive analysis of previously generated results.
  • Causa
    Siemens healthcare diagnostics has determined that there is a remote possibility for centralink to send an order to the advia automation system without specifying the type of sample. this event may occur when an order is received from the lis without the sample type information, requiring that such sample type information be placed in centralink based on the type of test sample in the order.
  • Acción
    Field Action Code ISW 17-01 triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA Company will send Notification to the client.

Device

ADVIA CENTRALINK Technical Name: Software ANVISA Registration Number: 10345161928 Hazard Class: I...

Manufacturer

Siemens Healthcare Diagnósticos S.A.; Siemens Healthcare Diagnostics Inc.
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    ANVSANVISA