Events

Retiro De Equipo (Recall) de Allen Medical Traction Boot

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 Allen Medical Systems Inc.

¿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
    14293
  • Fecha de inicio del evento
    2013-03-04
  • 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: Surgico Medical & Sugical Ltd, Unit A, 3 Whetu Place, Rosedale, North Shore City, AUCKLAND 0632
  • Causa
    The manufacturer advises that some units may have been assembled incorrectly which could result in the boot breaking from the mounting base causing the leg to fall. this potential defect could cause siginificant patient injury and may not be apparent to the user.
  • Acción
    Product to be returned to supplier

Device

Allen Medical Traction Boot

Manufacturer

Allen Medical Systems Inc