Events

Retiro De Equipo (Recall) de Liko Sabina and Capella Sit-to-Stand Mobile Lifts Manufactured before 31 May 2012

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-2012-RN-01141-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-12-03
  • 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-2012-RN-01141-1
  • 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 an issue related to the sabina and capella sit-to-stand mobile lifts. in certain situations, a patient, caregiver, or bystander could fall against the lift in such a way that the sling hook on the end of the slingbar could cause injury.
  • Acción
    The sponsor is providing work around instructions and will be providing replacement hooks when available.

Device

Liko Sabina and Capella Sit-to-Stand Mobile Lifts Manufactured before 31 May 2012
  • Modelo / Serial
    Liko Sabina and Capella Sit-to-Stand Mobile Lifts Manufactured before 31 May 2012Multiple model numbers and serial numbers.ARTG number 161863
  • Manufacturer
    Hill-Rom Pty Ltd

Manufacturer

Hill-Rom Pty Ltd