Events

Retiro De Equipo (Recall) de MultiDiagnost Eleva and MultDiagnost Eleva with Flat Detector (diagnostic fluoroscopic x-ray system)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Philips Electronics Australia 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-2016-RN-00943-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-07-15
  • 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-2016-RN-00943-1
  • 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
    The two bolts that attach the clamping plate to the lateral shaft may break. this may cause the c-arm to float freely. depending on the orientation of the free-floating c-arm and any other forces applied to it, the c-arm could move laterally forward, slide out of its bearings and then possibly sag. the sagging c-arm can strike a patient or operator. however, the probability of this occurring is rare. there have been no reports of injury associated with this event.
  • Acción
    Philips is advising users to be aware of the issue. If the C-arm moves in an unexpected manner, users should contact Philips immediately. Philips will be implementing a repair of the C-arm as a permanent correction. This action has been closed-out on 28/06/2017.

Device

MultiDiagnost Eleva and MultDiagnost Eleva with Flat Detector (diagnostic fluoroscopic x-ray system)
  • Modelo / Serial
    MultiDiagnost Eleva and MultDiagnost Eleva with Flat Detector (diagnostic fluoroscopic x-ray system)MultiDiagnost ElevaProduct Code: 708032MultiDiagnost Eleva with Flat DetectorProduct Code: 708034MultiDiagnost ElevaProduct Code: 708036MultiDiagnost Eleva with Flat DetectorProduct Code: 708037 MultiDiagnost Eleva with Flat DetectorProduct Code: 708038ARTG Number: 98560
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

Philips Electronics Australia Ltd
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    DHTGA