Events

Safety Alert for ELEKTA SOFTWARE FOR TREATMENT PLANNING. Models: MONACO and FOCAL. Anvisa Registry: 80569320003. (Update on 09/09/2014: Added FOCAL model)

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by IMPAC Medical Systems, Inc; Elekta Medical Systems Comércio e Serviços para Radioterapia 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
    1412
  • Date
    2014-08-12
  • 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
    As a consequence of the problem, the plan exported by the DICOM and the application of subsequent treatments would not correspond to the approved treatment plan. Thus, areas of the patient who should not receive doses may be treated and areas that should be treated may receive a dose that is higher or lower than the correct dose. According to the company's risk assessment, there is a remote possibility that the problem will lead to serious adverse health consequences.
  • Reason
    Incorrect handling when performing a dicom export of arcs using multiple field sequencing.
  • Action
    The company is providing a software fix for the problem. To avoid adverse events, do not use 180 ° as the starting angle of the gantry of the second bow - using 180.1 ° or 179.9 ° as the initial gantry angle completely eliminates the problem. Users should follow the guidance given in the Important Field Safety Notice and confirm receipt of the notice for the local Elekta contact as soon as possible. The important Notice of Field Security disclosed by the company is available at: http://portal.anvisa.gov.br/wps/connect/d8e83d004513a40c9130d7004acc0eea/Messagem+de+Alerta+%282%29.pdf?MOD=AJPERES

Device

ELEKTA SOFTWARE FOR TREATMENT PLANNING. Models: MONACO and FOCAL. Anvisa Registry: 80569320003. (...

Manufacturer

IMPAC Medical Systems, Inc; Elekta Medical Systems Comércio e Serviços para Radioterapia Ltda.
  • Manufacturer Parent Company (2017)
    Elekta AB
  • Source
    ANVSANVISA