Retiro De Equipo (Recall) de RAPIDPoint 400/405/500 Systems and RAPIDLab 1240/1245/1260/1265 Systems (blood gas analysers). An in vitro diagnostic medical device (IVD).

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Siemens Healthcare Pty Ltd.

¿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
  • ID del evento
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    Siemens has identified that when all of a particular set of steps occur 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 when those fields have been turned off for the system. the steps are: 1. analyser is configured with patient demographics (last name, first name) disabled and rapid sample identification transaction (host query) turned on. 2. patient id barcode is scanned at analysis screen prior to sample being analysed and is not the barcode for the patient sample being tested. 3. patient id and last name are not confirmed and/or corrected at the analysis screen. 4. the sample is analysed and correct patient id is entered at demographics screen.An incorrect patient name on the blood gas printout has the potential to lead to patient mismanagement.The patient id and patient test result data are correct on the analyser screen and the lis.
  • Acción
    Siemens is advising users to not configure the Siemens Blood Gas Analyser with the patient demographics (last name, first name) turned Off and the Rapid Sample Identification Option turned On. In addition, if sample IDs are scanned at the analysis screen, users should confirm that the patient ID is correct on the screen prior to analysing the sample. And, if the patient ID is not correct, correct it at the analysis screen.


  • Modelo / Serial
    RAPIDPoint 400/405/500 Systems and RAPIDLab 1240/1245/1260/1265 Systems (blood gas analysers). An in vitro diagnostic medical device (IVD).Various models affectedARTG Number: 175890
  • Manufacturer


  • Empresa matriz del fabricante (2017)
  • Source