Events

Retiro De Equipo (Recall) de DIMENSION VISTA SYSTEM - DIMENSION VISTA 1500 ANALYZER

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por SIEMENS HEALTHCARE LIMITED.

¿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
    24475
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2015-05-20
  • 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 # 1: manufacturer received complaints for samples not processing without notification on the dimension vista 500 or dimension vista 1500 using software versions 3.6.1 in most cases user action of pause / cancel pause is effective in restoring lane operation and the samples will resume processing. however in a few cases it was necessary to shutdown the instrument software and restart to recover. in all cases the affected samples are resubmitted and run successfully. issue # 2: manufacturer received complaints for unexpected less than lower assay range (

Device

DIMENSION VISTA SYSTEM - DIMENSION VISTA 1500 ANALYZER
  • Modelo / Serial
    Model Catalog: 1000033793 (Lot serial: >10 contact mfg.); Model Catalog: 1000034648 (Lot serial: >10 contact mfg.); Model Catalog: (Lot serial: >10 contact mfg.)
  • Descripción del producto
    DIMENSION VISTA SYSTEM - DIMENSION VISTA 1500 Analyzer
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

SIEMENS HEALTHCARE LIMITED
  • Dirección del fabricante
    OAKVILLE
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    HC