Events

Retiro De Equipo (Recall) de Radiometer ABL800 series blood gas analysers

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 Radiometer Medical ApS.

¿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
    21056
  • Fecha de inicio del evento
    2017-04-06
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • 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: Radiometer Pacific, Unit 3, 33 Spartan Road, Takanini 2105
  • Causa
    On the abl800 series analyzers the sample type cord blood has been changed into the two sample types cord blood arterial and cord blood venous. this change took place with software version 3.1 mr5. an operator or clinician who is aware that the sample types that can be selected on abl800 series analyzer are cord blood arterial and cord blood venous may notice that a less specific sample type cord blood appears in the his/lis or middleware system., followup april 2017: the final solution to this issue is an upgrade of the abl800 software to software version 6.17 or higher. this new version ensures that cord blood arterial and cord blood venous are transmitted correctly to a his/lis or a middleware system.
  • Acción
    Manufacturer to issue advice regarding use

Device

Radiometer ABL800 series blood gas analysers
  • Modelo / Serial
    Model: , Affected: All connected to HIS/LIS or middleware Data Management system
  • Manufacturer
    Radiometer Medical ApS

Manufacturer

Radiometer Medical ApS