Events

Retiro De Equipo (Recall) de Oxford Dipper Hoist

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Sunrise Medical Pty 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
    RC-2017-RN-01233-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-10-18
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01233-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    The manufacturer joerns healthcare has revised the service life statement and related manufacture guidance for the oxford dipper hoist. it is possible that issues such as corrosion can occur rapidly in units older than 7 years and this may not be externally visible to users. joerns healthcare strongly recommends load testing for the oxford dipper is carried out at each and every 6 monthly inspection due to the hostile environment in which it resides and operates. the humid and corrosive nature of the pool-side locations can potentially lead to product deficiencies that may otherwise remain undetected.
  • Acción
    Load testing for the Oxford Dipper should be carried out at every six-monthly inspection The Oxford Dippers that are older than 7 years need to be changed out prior to the following scheduled (6 monthly) inspection to ensure the ongoing safety of users. Recipients are requested to contact all customer(s) supplied with the supplied serial numbers, then complete the supplied Receipt Form with the appropriate box checked, according to disposition of each hoist as soon as the information becomes available or the change out is complete.

Device

Oxford Dipper Hoist
  • Modelo / Serial
    Oxford Dipper Hoist Models: OP10013, OP10014, X10013 and X10014Purchased between 2001 and 2010Multiple Serial Numbers affectedARTG Number: 101030
  • Manufacturer
    Sunrise Medical Pty Ltd

Manufacturer

Sunrise Medical Pty Ltd