Events

Alerta De Seguridad para 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

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Elekta Medical Systems Comércio e Serviços Radioterapia Ltda; IMPAC Medical Systems, Inc..

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    2243
  • Fecha
    2017-03-13
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    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.
  • Causa
    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.
  • Acción
    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.
  • Empresa matriz del fabricante (2017)
    Elekta AB
  • Source
    ANVSANVISA