Events

Retiro De Equipo (Recall) de ADVIA CENTAUR XPT INSTRUMENT

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
    43406
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2015-12-01
  • 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
    Siemens healthcare diagnostics has identified issues with the advia? centaur xpt system software v1.0.1 (bundle 1.0.912 smn 10819704) v1.0.2 (bundle 1.0.1086 smn 11219806) and v1.0.3 (bundle 1.0.1108 smn 11220781) that may affect the operation and workflow of the system. issues 1-12 will be corrected in software version 1.1 (bundle 1.1.243 smn: 11221979) which will soon be available for installation on all systems. the actions to be taken section indicates if the specific issue is corrected in v1.1. for issues corrected in software version 1.1 the actions do not need to be performed after the system has been upgraded to software version 1.1. issues 13-20 will be corrected in future software versions.

Device

ADVIA CENTAUR XPT INSTRUMENT
  • Modelo / Serial
    Model Catalog: 10711433 (Lot serial: 62866); Model Catalog: 10711433 (Lot serial: 10057); Model Catalog: 10711433 (Lot serial: 9223)
  • Descripción del producto
    ADVIA CENTAUR XPT INSTRUMENT
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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