Events

Safety Alert for SYSTEM OF PLANNING FOR ECLIPSE eMC RADIOTHERAPY - VERSION 6.5 A 8.9. Registro Anvisa n ° 10405410007. Products affected: http://migre.me/5LjBo.

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..

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
    1093
  • Date
    2011-09-22
  • 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
    See the Urgent Security Notice issued by Varian, available at http://migre.me/5LjBo.
  • Reason
    Configuring the eclipse emc algorithm, with non-equidistant data points in the open field profile, can lead to incorrect results. the problem may lead to an incorrect dose release in the lateral direction.
  • Action
    Varian has already started communicating the problem to all customers involved, according to a letter sent to UTVIG / ANVISA. If you are a user of the equipment in question, access the recommendations to users at http://migre.me/5LjBo.

Device

SYSTEM OF PLANNING FOR ECLIPSE eMC RADIOTHERAPY - VERSION 6.5 A 8.9. Registro Anvisa n ° 10405410...

Manufacturer

VARIAN MEDICAL SYSTEMS BRASIL LTDA.