Events

Retiro De Equipo (Recall) de EASYLINK INFORMATICS SYSTEM V3

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
    26036
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2011-12-07
  • 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
    When using the easylink quality control package qc results may be unexpectedly associated with a pending control. when this situation occurs pending qc controls may be created or reused. these pending qc controls are not used to evaluate whether the qc result has violated a qc rule therefore qc status may not be flagged appropriately. in addition patient results that were intended to be held through qc-related auto-verification rules may be released to the laboratory information system without appropriate intervention. systems that are using the laboratory information system or another application to manage qc results may see similar behavior transferred to the other systems. this behavior can be experienced under two different circumstances each with a different potential resolution.

Device

EASYLINK INFORMATICS SYSTEM V3
  • Modelo / Serial
    Model Catalog: 1000034805 (Lot serial: )
  • Descripción del producto
    EASYLINK INFORMATICS SYSTEM V5.0
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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