Retiro De Equipo (Recall) de Siemens RAPIDPoint 400/405/500 Systems and RAPIDLab 1200 Systemss

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Siemens Healthcare Diagnostics 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
    20545
  • Fecha de inicio del evento
    2016-08-19
  • País del evento
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Siemens Healthcare (NZ) Ltd, 55 Hugo Johnston Drive, Penrose, Auckland
  • Causa
    In an unlikely set of circumstances, there is a potential for the first and/or last name of one patient to be printed with patient id and result data from a different patient, even though those fields have been turned off on the system. the patient id and patient test result data, however, are correct on the analyser screen and the lis. only the printout may contain the incorrect first or last name data, which should not have been printed because those fields were turned off in setup.
  • Acción
    Manufacturer to issue advice regarding use

Device

  • Modelo / Serial
    Model: , Affected: RAPIDPoint® 400/405/500 Blood Gas Analyzer - RAPIDLab® 1240/1245/1260/1265 Blood Gas Analyzer
  • Manufacturer

Manufacturer

  • Empresa matriz del fabricante (2017)
  • Source
    NZMMDSA