Events

Alerte De Sécurité sur Trade name: ELEKTA PLANNING SYSTEM; ANVISA registration number: 80569320003; Risk class: III; Affected model (s): Monaco version 5.10; lot / series (local distribution district / UF): 5.10.02 (4 in São Paulo-SP, 1 in Belo Horizonte-MG, 1 in Santa Maria-RS); 5.10.00 (1 in Rio de Janeiro-RJ); 5.10.02 (1 in Pouso Alegre-MG)

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 Elekta Medical Systems Comércio e Serviços Radioterapia Ltda; IMPAC Medical Systems, Inc..

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
    1906
  • Date
    2016-06-07
  • 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
    Case of doubts about this action phone call: 8008784267
  • Cause
    Incorrect field size when dicom exporting monaco plan with composite field sequencing will fit in the port format when they remain where they are set. this runs when the shape of the door used to define or edit the mlc positions extend beyond or within the current grip positions. the defect was triggered when using an outdated workflow for the imrt planning for the future imrt which requires the creation of multiple beams for the same gantry angle with a single mlc format defined for each beam. these beams are then exported using cfs. there may be a possibility of a change in treatment planning, which could change the dose site and the amount received.
  • Action
    Action code FCA-IMS-0013. Software update /// Letter to customers elaborated on 06/03/2016.

Device

Trade name: ELEKTA PLANNING SYSTEM; ANVISA registration number: 80569320003; Risk class: III; Aff...

Manufacturer

Elekta Medical Systems Comércio e Serviços Radioterapia Ltda; IMPAC Medical Systems, Inc.
  • Société-mère du fabricant (2017)
    Elekta AB
  • Source
    ANVSANVISA