Events

Alerta De Seguridad para Registration number: ADVIA Centaur Systems //// Registration ANVISA: 10345161944. Risk class I //// model: ADVIA Centaur XPT /// Serial Numbers: IRL07221522; IRL08401537; IRL09721551; IRL09741551; IRL09801552; IRL10151604

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
    1927
  • Fecha
    2016-06-24
  • 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 you have any questions regarding this field action, please contact: E-mail temas.regulatorios.br@siemens.com Internet www.siemens.com Telephone 0800 129 633 Fax (11) 3908-3995
  • Causa
    The manufacturer has identified problems related to: sample tip error, daily maintenance, release of sample results below / above linearity, auto-repeat conditions processing of results it is possible that a sample tip error or a failure to complete the daily cleaning procedure, which could lead to discrepant results for patient samples and quality controls. according to the registrant of this product, the likelihood of these faults occurring is extremely unlikely (siemens points out that failure to complete the daily cleaning procedure may occur if fluid systems are not filled in prior to commencing the daily procedure). for the other problems described in the portuguese charter there is a potential for delay in releasing the result.
  • Acción
    Action code CSW 16-04. Letter Sending, prepared in May / 2016, to Customers.

Device

Registration number: ADVIA Centaur Systems //// Registration ANVISA: 10345161944. Risk class I //...

Manufacturer

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