Events

Retiro De Equipo (Recall) de ABL90Flex analyser

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
    23011
  • Fecha de inicio del evento
    2018-05-23
  • 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
    The manufacturer has recently become aware that the abl90 flex in a very rare specific situation can aspirate cal 2 solution instead of rinse solution., the specific situation can occur when the following take place:, 1. the analyzer is in ready mode, 2. operator lifts the inlet and then closes it again, thereby initiating a rinse, 3. immediately after lifts the inlet and quickly closes it again.
  • Acción
    Software to be upgraded

Device

ABL90Flex analyser
  • Modelo / Serial
    Model: All analysers with software version 3.3MR1 or lower, Affected:
  • Manufacturer
    Radiometer Medical ApS

Manufacturer

Radiometer Medical ApS