Events

Safety Alert for THREE-DIMENSIONAL PLANNING SYSTEM FOR ECLIPSE RADIOTHERAPY. ANVISA Registration No. 10405410007.

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
    1188
  • Date
    2012-10-03
  • 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
    Additional information available in the warning message published by the company at http://portal.anvisa.gov.br/wps/wcm/connect/d7a881004cf28281bdd1bf551355428f/Messaje+de+Alerta_1188.pdf?MOD=AJPERES. The company did not report the date of completion of the fix. #### UPDATE (06/07/2013): The company completed the field action on 04/29/2013, correcting the 52 units under risk in Brazil.
  • Reason
    Possibility of calculation and application of incorrect dose of radiation, due to lack of synchronism between the clocks of the workstation and the server of the system / database.
  • Action
    The company is notifying its customers through an "Urgent Security Warning" notice, which advises users to check the synchronization between Workstation and System / Database Server clocks. The company is developing a technical solution to the problem (software).

Device

THREE-DIMENSIONAL PLANNING SYSTEM FOR ECLIPSE RADIOTHERAPY. ANVISA Registration No. 10405410007.

Manufacturer

VARIAN MEDICAL SYSTEMS BRASIL LTDA.