Events

Retiro De Equipo (Recall) de Nortec patient lifting sling

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 Zenitec Holdings 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
    20957
  • Fecha de inicio del evento
    2017-01-18
  • 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: Zenitec Holdings Ltd, 135-137 Ettrick St, Invercargill 9840
  • Causa
    There have been four recorded cases of failure of the keyhole clip that attaches a sling to a pivot framed hoist. these keyhole clips are the black plastic component this is attached to the sling by means of a webbing strap threaded through a slot. the affected clips have all broken at the slot., the fault has been tracked to two batches of product which were made with incorrect machine settings by the clip manufacturer.
  • Acción
    Product to be exchanged

Device

Nortec patient lifting sling

Manufacturer

Zenitec Holdings Ltd