Events

Retiro De Equipo (Recall) de Liko Viking mobile lifts(Liko Lift devices are intended to lift and/or transfer the patients between floors, beds, chairs, etc, from one position to another.)

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-2015-RN-00893-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-09-10
  • 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-2015-RN-00893-1
  • 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 9 complaints where it has been described that the lift arm drifted down suddenly on certain viking mobile lifts. these reports have been connected to users who raise the lift arm assembly manually.The lift arm assembly is intended to only be raised by the actuator (lift motor). if the lift arm assembly is manually raised, the actuator can become damaged and get stuck in the highest position. when the actuator is stuck, the lift cannot be raised or lowered by the lift motor. hill-rom requests customers do not raise the lift arm manually since the lifting actuator can become stuck and/or become damaged.
  • Acción
    Hill-Rom is conducting a correction in two phases. Phase 1 will be this letter and information for you to update the Instruction Guides. Phase 2 will include the physical inspection of potentially affected devices. If there is damage to the actuator consistent with manually lifting, the actuator will be replaced by Hill-Rom.

Device

Liko Viking mobile lifts(Liko Lift devices are intended to lift and/or transfer the patients betw...
  • Modelo / Serial
    Liko Viking mobile lifts(Liko Lift devices are intended to lift and/or transfer the patients between floors, beds, chairs, etc, from one position to another.)Affected Models:-Viking MModel 2040035 (S/N 9 200 000 – 9 201 689)Model 2040015 (S/N 7 500 401 – 7 568 899)Model 2040005 (S/N 7 100 101 – 7 200 200)Viking LModel 2040004 (S/N 7 200 201 – 7 300 300)Viking XL or Viking 300 LiftModel 2040003 (S/N 801 301 – 804 999)ARTG Numbers: 161863
  • Manufacturer
    Hill-Rom Pty Ltd

Manufacturer

Hill-Rom Pty Ltd