Events

Alerte De Sécurité sur Commercial Name: ELEKTA PLANNING SYSTEM Technical Name: ELEKTA PLANNING SYSTEM ANVISA Registration Number: 80569320003 Hazard Class: III Model Affected: Monaco Serial Numbers Affected: Monaco 5.00 and above

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
    2243
  • Date
    2017-03-13
  • 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
    The problem is detectable when following routine procedures to commission a beam model. A reminder can be used that when reinstalling a beam model, it is also necessary to repeat the quality control checks performed on the original model.
  • Cause
    Incorrect dynamic wedge (edw) or virtual wedge (vw) calculations the edw or vw wedge files can be loaded into the wrong energies using the drive unit storage. no notice or consistency check is performed on the edw or vw files when added to the database. the treatment unit storage should not allow or should display an error message if the user attempts to add an edw or vw file to a given power beam to a cone model file retracted at a different energy. currently the user is not warned if there is an incompatibility.
  • Action
    Field Action Code FCA-IMS-0021 triggered under the responsibility of Elekta Medical Systems Comércio e Serviços Radiotherapy Ltda. Company will make correction in the field.

Device

Commercial Name: ELEKTA PLANNING SYSTEM Technical Name: ELEKTA PLANNING SYSTEM ANVISA Registratio...

Manufacturer

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