Events

Retiro De Equipo (Recall) de LIKO SlingBar 350, SlingBar 360, SlingBar Wide 670 and SideBar Standard

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-2013-RN-01059-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-11-21
  • 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-2013-RN-01059-1
  • 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 become aware of a potential safety issue related to the slingbar 350, slingbar 360, slingbar wide 670 and sidebar standard, which could be attached to various liko overhead and mobile lifts. a serious injury to a patient, caregiver, or bystander could result from tripping or otherwise falling in to the sling bar, typically while the lift is parked or stored when not in use. the sling hook on the end of the sling bar could pierce a body structure, such as the head, shoulder, or groin.
  • Acción
    Hill-Rom is providing replacement sling bars to mitigate the issue. This action has been closed-out on 27/01/2016

Device

LIKO SlingBar 350, SlingBar 360, SlingBar Wide 670 and SideBar Standard
  • Modelo / Serial
    LIKO SlingBar 350, SlingBar 360, SlingBar Wide 670 and SideBar StandardProduct Numbers: 3156015, 3156002, 3156008, 3156004, 3156013, 3156012, 3156017 or 3156011Distributed between April 1998 and May 2008
  • Manufacturer
    Hill-Rom Pty Ltd

Manufacturer

Hill-Rom Pty Ltd