Events

Alerta De Seguridad para EXACT TARGETING MESA, component of the following products: ACUITY RADIAC THERAPY SIMULATOR (Anvisa 10405410008), LINEAR ACCELERATOR CLINAC IX AND ACCESSORIES (Anvisa Reg 10405410012), VARIAN RADIOTHERAPY SYSTEM (10405410011), CLINAC RADIOTHERAPY LINEAR ACCELERATORS (10405410001) and LINEAR HIGH-ENERGY RADIOTHERAPY ACCELERATOR CLINAC (10405410010).

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Varian Medical Systems Brasil Ltda.; Varian 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
    1037
  • Fecha
    2010-12-15
  • 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 EXaCT Targeting table is a complex mechanical device that can trap and injure the extremities of the human body, especially the fingers. Documentation already provided by Varian for this table includes warnings about these risks and instructions for safe use of the table. According to Varian, in the past mitigation measures have been taken.
  • Causa
    Grooves on the tables can hold and injure parts of the operator's or patient's extremities, such as the fingers and toes.
  • Acción
    Users of Exact Targeting should pay attention to the following instructions: Read and follow the recommendations and safety instructions in the user manual that came with the product, especially the chapter "Hazard and Safety Precautions" ). Maximum caution is advised when two people handle the table simultaneously. Patients should be advised to hold only the appropriate handles and guides on the table to avoid inserting their fingers into risky places. For detailed safety instructions, please read the Urgent Safety Notice posted by the manufacturer of the product at: http://portal.anvisa.gov.br/wps/wcm/connect/313eef8045112cd3ac7daeb34d2284eb/VarianSecurity Notice. pdf? MOD = AJPERES.

Device

EXACT TARGETING MESA, component of the following products: ACUITY RADIAC THERAPY SIMULATOR (Anvis...

Manufacturer

Varian Medical Systems Brasil Ltda.; Varian Inc.