Events

Retiro De Equipo (Recall) de MAQUET VOLISTA central handle on StanOP, TRIPOD and ACCESS Cupolas

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Getinge Australia 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-2018-RN-00045-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-01-16
  • 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-2018-RN-00045-1
  • 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
    Getinge has received complaints indicating that the central handle holder detaches easily from the cupola during use. we determined that the root cause of this malfunction is excessive tightening of the screws during mounting of the handle holder, resulting in the rivets loosening and detaching from the central handle holder ring.During manipulation, the handle holder may completely detach from the light head, if all three rivets loosen simultaneously. in this case, although the handle remains in the user’s hand, small quantities of particles may be generated from the plastic holder ring.
  • Acción
    Getinge will be in contact with affected users to arrange for a service technician to replace existing central holder rings.

Device

MAQUET VOLISTA central handle on StanOP, TRIPOD and ACCESS Cupolas
  • Modelo / Serial
    MAQUET VOLISTA central handle on StanOP, TRIPOD and ACCESS Cupolas Part Numbers: ARD568811950, ARD568811960, ARD568811961, ARD568811962, ARD568812910, ARD568812950, ARD568812960, ARD5688112962, ARD568821913,Serial Numbers (up to, for the above part numbers respectively): 50000, 500063, 500003, 500030, 500004, 50000, 500046, 500007, 500001ARTG Number: 162037 (Getinge Australia Pty Ltd - Light, surgical)
  • Manufacturer
    Getinge Australia Pty Ltd

Manufacturer

Getinge Australia Pty Ltd
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    DHTGA