Events

Retiro De Equipo (Recall) de T2100 and T2000 Treadmill power cords

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-00128-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-02-18
  • 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-00128-1
  • 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 ge healthcare internal quality inspection has found that the power cord connecting directly to the t2100 and t2000 treadmills may not have been assembled according to specifications. if the power cord was improperly assembled and a separate secondary electrical fault condition exists (e.G., a frayed extension or power cord touching the treadmill chassis), this could possibly result in an electrical shock to the patient or operator. there have been no reported incidences of the treadmill power cord leading to an electrical shock of a patient or operator at this time.
  • Acción
    GE Healthcare is instructing customers to continue to perform the routine maintenance specified in the T2100 T2000 Service Manuals. This includes the leakage tests performed after each monthly internal cleaning, as specified in the T2100 and T2000 Service Manuals. A GE Healthcare Service Representative will contact customers to arrange a correction. This action has been closed-out on 15/08/2016.

Device

T2100 and T2000 Treadmill power cords

Manufacturer

GE Healthcare Australia Pty Ltd