Events

Retiro De Equipo (Recall) de T2100 Treadmill

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por GE Healthcare Australia Pty Ltd.

¿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
    RC-2015-RN-00259-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-03-19
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00259-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    A performance issue with the t2100 treadmills can cause uncontrolled walking belt motion during a stress exercise test. this motion can be seen as an unexpected slowing, followed by sudden belt acceleration in either the forward or backward direction. when this occurs, engaging the emergency stop button (estop) will not immediately stop the belt. rather, it will coast to a stop within 35 seconds when slowing from maximum speed. the sudden change in belt speed and/or direction can result in a fall and injury to the patient.
  • Acción
    GE Healthcare is providing work around instructions to minimise the risk of an unexpected change in speed or direction. GE will correct all affected units onsite. This action has been closed-out on 12/08/2016.

Device

T2100 Treadmill

Manufacturer

GE Healthcare Australia Pty Ltd