Retiro De Equipo (Recall) de GE CareScape Patient Monitor, Multi-Parameter

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 GE Healthcare Finland Oy.

¿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: GE Healthcare Limited, 8 Tangihua Street, Auckland 1010
  • Causa
    When connecting the pdm (patient data module) to the carescape b850, b650 or b450 monitor with software version 2 the pdm may not start communicating to the monitor and loss of the pdm parameters could occur., this issue happens after the following sequence of events:, 1. the pdm is connected to a transport pro or solar monitor., 2. at least one arrhythmia or st-change snapshot is saved in the pdm., 3. the pdm is then connected to the carescape bx50 monitor., 4. more than 740 arrhythmia or st-change snapshots are then saved in the pdm., 5. the pdm is then disconnected and connected back to the carescape bx50 monitor.
  • Acción
    Software to be upgraded


  • Modelo / Serial
    Model: Models: B850, B650, B450, Affected: , Software version: Version 2 software
  • Manufacturer