Events

Alerta De Seguridad para Trade name: APTIO AUTOMATION; APTIO Automation Technical name: EQUIPMENT FOR PREPARING SAMPLES FOR IN VITRO DIAGNOSIS; Instrument exclusively intended for joining modules, integration of analyzers or test platforms. ANVISA Registration Number: 10345161904; 10345162051 Hazard Class: I Model Affected: Serial Numbers Affected: 808B-14-170; 808B-14-171; TSD-14-228; 808B-15-239; 808B-15-331; TSD-15-391; TSD-15-392

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.

¿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
    2088
  • Fecha
    2016-10-28
  • 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 Siemens engineering team will visit the lab to exchange these power cables.
  • Causa
    Modules and their respective interface modules affected by this field action include a power cable that has two connectors that allow for two possible configurations. siemens healthcare diagnostics has been informed by our suppliers that the connector used to connect the modules to the power source of the automation system may overheat. the connector used to connect to a standard power source is not impacted by this problem.
  • Acción
    Field Action Code LAI 16-03 triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA Company will send Letter to the Client.

Device

Trade name: APTIO AUTOMATION; APTIO Automation Technical name: EQUIPMENT FOR PREPARING SAMPLES FO...

Manufacturer

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