Events

Retiro De Equipo (Recall) de Sunrise Medical Sunlift 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-2014-RN-01057-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-11-21
  • 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-2014-RN-01057-1
  • 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
    Sunrise medical is issuing a product notification following the return of 2 hoists model g175 due to the legs moving in an incorrect “v” position.Distributors and consumers are being notified of important new information relating to conditions of use and revised inspection criteria. the revised information covers conditions of use, daily checks, and ongoing maintenance requirements which will reduce possible damage to the hoist legs which in turn may affect the stability of the hoist.
  • Acción
    Sunrise Medical is providing an updated user manual and advising users of the correct use of the Sunlift hoist. Sunrise Medical is requesting the customers to check the parallelism of the legs of the hoist. If the legs are toed inwards by more than 3 degrees and not parallel Sunrise is requesting the user not to use the hoist in this position. Sunrise Medical is also providing an interface bracket with fitting instructions to ensure the legs will not turn inwards. The parts will be supplied Free-of-Charge. This action has been closed-out on 18/04/2017.

Device

Sunrise Medical Sunlift Hoist
  • Modelo / Serial
    Sunrise Medical Sunlift Hoist Models: G150E & G175EARTG # 101030
  • Manufacturer
    Sunrise Medical Pty Ltd

Manufacturer

Sunrise Medical Pty Ltd