Events

Retiro De Equipo (Recall) de Radiometer ABL800 series blood gas analyser with FLEXQ module

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
    22096
  • Fecha de inicio del evento
    2018-01-09
  • 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
    It has come to the manufacturers attention that in certain situations, the registration receipt received after placing a sampler in the flexq can be associated with a different sampler if the barcode quality on the receipt has been affected., update:, the manufacturer has now released the software upgrade version6.18 which is the corrective action for the issue reported., a checksum has been added to the barcode on the registration receipt to make the barcode more robust.
  • Acción
    Software to be upgraded

Device

Radiometer ABL800 series blood gas analyser with FLEXQ module
  • Modelo / Serial
    Model: , Affected: Sampler Registration receipt data, All serial numbers
  • Manufacturer
    Radiometer Medical ApS

Manufacturer

Radiometer Medical ApS