Retiro De Equipo (Recall) de Radiometer AQURE Data Management System

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
  • ID del evento
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Manufacturer has recently become aware of a potential clinical issue with aqure if the data management system is being used to interpret patient results for the management of treatment., in aqure, there are two views called flexlink and patient view. each can display multiple patient result values from a single patient, provided over time, from one or multiple devices. this screen is intended to be reviewed by a clinician., the issue occurs when a sample type is not provided from a device. an example is where results from a sample type of “urine” (not displayed) is compared to results from a sample type “arterial”. in this case a clinician may incorrectly take action based on an assumption that all results are from a sample type “arterial”.
  • Acción
    Software to be upgraded


  • Modelo / Serial
    Model: , Affected: , Software version: all software versions below V2.1.1
  • Manufacturer