Events

Alerte De Sécurité sur ELEKTA SOFTWARE FOR TREATMENT PLANNING. Models: MONACO and FOCAL. Anvisa Registry: 80569320003. (Update on 09/09/2014: Added FOCAL model)

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par IMPAC Medical Systems, Inc; Elekta Medical Systems Comércio e Serviços para Radioterapia Ltda..

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    1412
  • Date
    2014-08-12
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    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.
  • Cause
    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.
  • Société-mère du fabricant (2017)
    Elekta AB
  • Source
    ANVSANVISA