Events

Alerta De Seguridad para CLINITEK Status +, Brand: Siemens, Registration: 10345161788, risk class: I. ////. CLINITEK Status, Mark: Siemens, Registration: 10345160454, hazard class: I .. Serial numbers: SEE ANNEX

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 Ltda.; 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
    1511
  • Fecha
    2014-10-21
  • 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
    According to the record-holder, a problem with the equipment's power adapter may result in increased potential for electric shock to the user.
  • Causa
    Siemens healthcare diagnostics reported damage to the external power adapters that come with clinitek status®, clinitek status® +, and clinitek connect status® connected to the urine analyzers.
  • Acción
    Siemens advises its customers to turn off the device and disconnect the power adapter from the power outlet to check the Code Identification Register raised. • If your power adapter has one of the aforementioned raised ID codes, immediately stop use and discard the power adapter. • If your power adapter does not have one of the ID codes listed above but is cracked or damaged in some way, immediately stop use and discard the adapter.

Device

CLINITEK Status +, Brand: Siemens, Registration: 10345161788, risk class: I. ////. CLINITEK Statu...

Manufacturer

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