Events

Alerte De Sécurité sur Trade Name: ELEKTA PLANNING SYSTEM Technical Name: ANVISA Registration Number: 80569320003 Hazard Class: III Model Affected: Monaco Serial Numbers Affected: Monaco 5.10.2

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
    2179
  • Date
    2016-10-17
  • 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
    Prior to treatment, independent and secondary findings of dose calculation and UM should be performed. Both checks should be standard clinical radiotherapy practices and will detect the problem. The problem can be avoided by forcing a new calculation on Monaco® (change the spacing of the dose calculation grid and return again) when any change in wedge angle is made. Clients should follow the directions in the Field Action release until corrections are implemented.
  • Cause
    Incorrect monitoring unit scale when creating 3d plans using um or dose-weighted modes, if the user changes the number of fractions and / or dose rx desired by the physician and then modifies the angle of the wedge, the value of the one will be scaled incorrectly. the um scale is directly proportional to the fractional change.
  • Action
    Field Action Code FCA-IMS-0017 triggered under the responsibility of Elekta Medical Systems Comércio e Serviços Radiotherapy Ltda. Company will make correction in the field.

Device

Trade Name: ELEKTA PLANNING SYSTEM Technical Name: ANVISA Registration Number: 80569320003 Hazard...

Manufacturer

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