Events

Retiro De Equipo (Recall) de Radiometer ABL90Flex/ ABL90Flex Plus 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
    20640
  • Fecha de inicio del evento
    2016-09-19
  • 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
    Potential risk that the analyser may report patient sample results although the analyser performance has not been verified by running quality controls. this situation may occur if the customer selects the "exit conditioning" option when a new sensor cassette is loaded.
  • Acción
    Manufacturer to issue advice regarding use

Device

Radiometer ABL90Flex/ ABL90Flex Plus Blood Gas Analysers
  • Modelo / Serial
    Model: , Affected: , Software version: ALL running software below ver3.2
  • Manufacturer
    Radiometer Medical ApS

Manufacturer

Radiometer Medical ApS