Events

Retiro De Equipo (Recall) de GE T2100 and T2000 Treadmills, power cord

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 Medical Systems Information Technologies.

¿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
    18116
  • Fecha de inicio del evento
    2015-02-20
  • 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: GE Healthcare Limited, 8 Tangihua Street, Auckland 1010
  • 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
    Product to be modified

Device

GE T2100 and T2000 Treadmills, power cord
  • Modelo / Serial
    Model: T2100 & T2000, Affected: 408930-001 Manf between 1-Jun-2006 and 10-Dec-2014: 408930-002 Manf between 1-Jun-2006 and 19-Jan-2015: 2028038-008 Manf between 1-Dec-2006 and 28-Jan-2015
  • Manufacturer
    GE Medical Systems Information Technologies

Manufacturer

GE Medical Systems Information Technologies