Events

Retiro De Equipo (Recall) de SEQUENCER

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por ELEKTA BUSINESS AREA SOFTWARE SYSTEMS IMPAC MEDICAL SYSTEMS INC..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    33120
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2011-11-08
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 recall data from the U.S. and Canada.
  • Notas adicionales en la data
  • Causa
    Issue with mosaiq that could affect any treatment field defined with mlc leaves at the time of rtp import of treatment plans. a product defect truncates the mlc leaf values upon the import of a treatment plan after the 3d image viewer has been opened if the workstation on which the import was executed is configured to use a comma() as the decimal separator. this involves sequencer for mosaiq 2.20.08 (first build released may 2011) including all released builds and service packs of version and version 2.00x3sp6 (first build released sept 2011).

Device

SEQUENCER

Manufacturer

ELEKTA BUSINESS AREA SOFTWARE SYSTEMS IMPAC MEDICAL SYSTEMS INC.
  • Dirección del fabricante
    SUNNYVALE
  • Empresa matriz del fabricante (2017)
    Elekta AB
  • Source
    HC