Events

Retiro De Equipo (Recall) de Ceiling Bracket, Arch 71 White (used for installing Liko patient lifts to wooden and concrete ceilings)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Hill-Rom 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-2016-RN-01014-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-08-15
  • 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-2016-RN-01014-1
  • 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
    Hill-rom has received one complaint where the ceiling bracket 71 has been shipped with an increased size of the center hole.A potentially hazardous situation exists if the ceiling bracket 71 with a larger center hole is used for a concrete ceiling installation since a m8 screw and washer will be used. analysis has shown that if the bracket is mounted with a m8 screw and washer in a concrete ceiling ultra system installation (maximum load of 400 – 500 kg) there is a safety hazard associated with the installation that could potentially cause the system to fall.
  • Acción
    Hill-Rom is advising the distributor to inspect stock and quarantine the affected brackets for return. All the affected stock is with the distributor. This action has been closed-out on 10/05/2017.

Device

Ceiling Bracket, Arch 71 White (used for installing Liko patient lifts to wooden and concrete cei...
  • Modelo / Serial
    Ceiling Bracket, Arch 71 White (used for installing Liko patient lifts to wooden and concrete ceilings)Product code: 3102071 ARTG number: 161863
  • Manufacturer
    Hill-Rom Pty Ltd

Manufacturer

Hill-Rom Pty Ltd