Events

Alerta De Seguridad para SYSTEM DIMENSION EXL - Registration nº 10345161695. Serial Numbers: 12251428; 12252714.

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 Diagnóstics 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
    1763
  • Fecha
    2015-12-01
  • 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 the absence of the safety cover can cause a risk of electric shock to the operator. This question does not affect patient outcomes.
  • Causa
    Siemens healthcare has identified that in some rms refrigeration compressors, safety cover may be missing, in the electrical termination block. exposure to electrical risk in the electrical termination block is located immediately behind the rms waste container.
  • Acción
    Care should be taken when removing the waste container from the RMS module. Under no circumstances should you place your hands in the RMS cabinet beyond what is necessary to remove the waste container. If any flex cartridge drops out of the waste container, do not enter the RMS cabinet to remove it. In addition, the WARNING page posted within the Warning Message should be attached on the outside of each RMS cabinet the customer owns, serving as a temporary warning to all operators until the machines are inspected. Please note that only customers who own the RMS module (optional) will be subject to the field action. (Code DI 16-01)

Device

SYSTEM DIMENSION EXL - Registration nº 10345161695. Serial Numbers: 12251428; 12252714.

Manufacturer

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