Events

Retiro De Equipo (Recall) de JCM Compact Base for Neptune and Triton wheelchairs

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 JCM Seating Solutions 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
    19125
  • Fecha de inicio del evento
    2015-09-15
  • 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
    Jcm has received reports of isolated incidents involving the instability of the compact base when used in certain conditions. whilst the compact base design in itself is structurally sound and has no mechanical issue, the following guidelines have been revised for safe use:, * the compact base should be used with the neptune size 1 and triton size 0 chairs only, * maximum user weight to compact base should not exceed 40kg., * any seating system larger than the neptune size 1 and triton size 0 should be used with a multi height & tilt base or other approved jcm base/wheelchair base to ensure complete stability.
  • Acción
    Instructions for use to be updated

Device

JCM Compact Base for Neptune and Triton wheelchairs

Manufacturer

JCM Seating Solutions Ltd