Events

Safety Alert for Three-dimensional Planning System for Eclipse Radiotherapy, model eclipse versions 11; 13.0; 13.5 and 13.6, registration 10405410007, risk class III, various series.

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
    1822
  • Date
    2016-02-04
  • 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
    Recommendations for users and patients: DO NOT USE Eclipse versions 11, 13, 13.5 or 13.6 with the PBC 11.0.31 algorithm for conventional arc field dose calculation. #### UPDATED ON 10/25/2017, the company submitted completion report of the field action proving the accomplishment of correction as planned.
  • Reason
    An anomaly was identified with the eclipse three-dimensional planning system using pbc 11.0.31 to calculate a conventional arcuate dose distribution. when using pbc 11.0.31 to calculate the dose for a conventional arc field with more than 100 segments with eclipse versions 11.0, 13.0, 13.5 or 13.6, the displayed dose does not correspond to the monitor units ( mu) calculated. potential for unintentional radiation exposure.
  • Action
    Action code CP-23187. Varian Medical Systems Brazil has sent a Letter of Safety dated January 11, 2016 to all affected customers. The letter describes affected models, problem and necessary actions, among them the software update. For customer questions related to this help desk action of Varian Telephone: + 1-888-827-4265; E-mail: support@varian.com

Device

Three-dimensional Planning System for Eclipse Radiotherapy, model eclipse versions 11; 13.0; 13.5...

Manufacturer

Varian Medical Systems Brasil Ltda.; Varian Medical Systems.