Alerta De Seguridad para AXIOM ARTIS, Artis dFA and Artis dFC models, registration 10234230096; serial numbers affected: 35117; 35318; 35396; 35485; 35622; 35729; 35748; 35751; 35817; 35862; 35872; 35883; 35884; 35885; 35910; 35913; 35936; 35949; 50138. Risk class III

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Siemens Ltda.; SIEMENS AG..

¿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
    1708
  • Fecha
    2015-10-02
  • País del evento
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
  • 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 registry holder informs that the system will not move by itself and must be started by the operator. When moving, the system may unexpectedly exceed its normal speed, with possibility of collision. In addition to correcting the failure, the software update will provide fixes for the operating system as well as a new version of anti-virus protection.
  • Causa
    The company has identified position sensor failure on the oscillating base axis that is not detected by the system software. after activation of the movement by the operator, the arm system c can move unexpectedly faster than normal.
  • Acción
    Updating the VB35D software version to fix the problem. The customer may continue to use the equipment while awaiting the appointment of the engineer.

Manufacturer

  • Empresa matriz del fabricante (2017)
  • Source
    ANVSANVISA