Alerta De Seguridad para Trade name: APTIO AUTOMATION. ANVISA registration number: 10345161904. Hazard class: I. Affected serial numbers: APT.0154.12.14; APT.0133.09.14; APT.0179.02.15; APT.0209.04.15; APT.0266.10.15

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
    1930
  • Fecha
    2016-06-16
  • 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
    Recommendation to users and patients: Siemens HealthCare Diagnostics suggests that the instructions provided by the Hettich company be followed. Siemens Healthcare Diagnostics strongly recommends that centrifuge maintenance be performed according to the instructions described in the User's Guide and at the indicated intervals. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link
  • Causa
    The field action lai 16-02 refers to the supports that are used in the hettich rotanta 46 rsc robotic and rotanta 460 robotic centrifuges centrifuges. there may be faulty support during the procedure, such as moving or rotating the centrifuge.
  • Acción
    The field action code LAI 16-02 initiated by Siemens deals with the sending of a Letter to the Customer - Safety Alert Recommendation to users and patients: Siemens HealthCare Diagnostics suggests that the instructions provided by the company Hettich be followed. Siemens Healthcare Diagnostics strongly recommends that centrifuge maintenance be performed according to the instructions described in the User's Guide and at the indicated intervals.

Manufacturer