Events

Retiro De Equipo (Recall) de Handicare System RoMedic ReTurn 7400 and 7500 Patient Transfer device

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 Handicare AB.

¿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
    16761
  • Fecha de inicio del evento
    2014-07-28
  • 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: Active Rehab Equipment, 25 Rennie Drive, Airport Oaks, Auckland
  • Causa
    During the period april 2009 to may 2011, handicare ab used a wing handle in which the screw and the handle, after repeated tightening, may slide apart. this causes a small play in the attachment of the ladder, which in turn results in high load at the attachment holes of the ladder. eventually this may cause mechanical fatigue in the material of the ladder.
  • Acción
    Product to be modified

Device

Handicare System RoMedic ReTurn 7400 and 7500 Patient Transfer device
  • Modelo / Serial
    Model: Models 7400 and 7500, Affected: Manufactured between Apr-2009 and May 2011
  • Manufacturer
    Handicare AB

Manufacturer

Handicare AB