Events

Alerta De Seguridad para Trade name: Vitesse; Variseed Technical name: ANVISA registration number: 10405410021; 10405410024 Hazard Class: III Affected Model Number: Not applicable Serial Numbers Affected: H621016, H6T0145, H6T0157, H6T0149, H6T0176, H6T0184.

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
    2164
  • Fecha
    2016-10-07
  • 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 recommends that users make operating system adjustments to eliminate freezing of VariSeed ™ or Vitesse ™ when the Windows ™ Update Agent accesses the system as described in BT-02323. ### UPDATED ON 10/25/2017, the company sent the field action completion report, verifying the sending of the security warning to the client.
  • Causa
    Varian has received reports of an anomaly that occurs with variseed ™ 9.0 or vitesse ™ 3.0 that could affect the deployment treatment sessions. the microsoft windows ™ operating system update agent causes a system freeze when you use a lot of cpu resources. if the windows ™ update agent accesses the operating system while variseed ™ 9.0 or vitesse ™ 3.0 is running, this may cause the application to freeze.
  • Acción
    Field Action Code BT-02323 triggered under the responsibility of the company Varian Medical Systems Brazil Ltda. Company will notify.

Device

Trade name: Vitesse; Variseed Technical name: ANVISA registration number: 10405410021; 1040541002...

Manufacturer

Varian Medical Systems Brasil Ltda; Varian Medical Systems