Events

Retiro De Equipo (Recall) de Medifab Shuttle Discovery System

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 Medifab Medical Fabrication.

¿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
    19187
  • Fecha de inicio del evento
    2015-10-06
  • 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: Medifab Medical Fabrication, 32 Detroit Drive, Izone Business Hub, Rolleston 7675
  • Causa
    The manufacturer has identified two potential issues relating to the backrest and the tilt in space locking plunger should the vehicle used to transport the end user in the discovery buggy be involved in an accident., 1/ there is potential for the s tubes to come out of the mounting block, 2/ there is potential that the discovery seat may tilt back due to the tilt in space plungers not being engaged in the plastic slides.
  • Acción
    Product to be modified

Device

Medifab Shuttle Discovery System
  • Modelo / Serial
    Model: 2006-0010-000, Affected: JS-06-14-DS-**, JS-15-14-DS-**, JS-18-14-DS-**, JS-23-14-DS-**, JS-45-14-DS-**, JS-46-14-DS-**, ML-8-15-DS-**, ML-13-15-DS-**, ML-16-15-DS-**, ML-17-15-DS-**, ML-18-15-DS-**, 61427, 61738
  • Manufacturer
    Medifab Medical Fabrication

Manufacturer

Medifab Medical Fabrication