Events

Safety Alert for 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.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Varian Medical Systems Brasil Ltda; Varian Medical Systems.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    2164
  • Date
    2016-10-07
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the 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.
  • Reason
    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.
  • Action
    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