Events

Alerta De Seguridad para Trade name: ARIA Technical name: ANVISA registration number: 10405410013 Hazard class: III Affected model: Not applicable Serial numbers affected: HIT7141; HIT7275; HIT7004; HIT4376M; HIT7271; HIT4376R1; HIT7175; HIT1827; HIT6999; HIT6238; HIT3172; HIT4459; HIT7248; HIT2388; HIT7084; HIT1741; HIT5549; HIT7541; HIT7576; HIT3931; HIT7140; HIT6154

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 Medical Systems.

¿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
    2163
  • Fecha
    2016-09-13
  • 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
    Varian emphasizes the recommendation that users verify the values ​​of limitations and correlates with the nomenclature before creating a treatment plan. Varian Medical Systems is developing a technical fix for this problem. You will be contacted by a customer service representative when this fix is ​​available to schedule the installation on your system.
  • Causa
    An abnormality was identified in version 13.6 of the prescribe treatment regarding the storage and subsequent exposure of organ-at-risk (oar) dose-limitation values. the oar limit values ​​are displayed incorrectly on the prescribe treatment 13.6 workspace if the prescription has been created in versions 11.0, 13.0, or 13.5. the storage location of dosage and volume limiters has been changed in version 13.6. as a result of this problem, the display of the dosage-volume limiters will differ according to the version in which they were created and the version of the workspace in which they are displayed.
  • Acción
    Field Action Code CP-26231 triggered under the responsibility of the company Varian Medical Systems Brazil Ltda. Company will make correction in the field.

Device

Trade name: ARIA Technical name: ANVISA registration number: 10405410013 Hazard class: III Affect...

Manufacturer

Varian Medical Systems Brasil Ltda; Varian Medical Systems