Events

Retiro De Equipo (Recall) de DuraDiagnost Release 1.0, 2.0, 3.0 X-Ray systems

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-2017-RN-00726-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2017-06-01
  • 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-2017-RN-00726-1
  • 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
    Philips has discovered via a report from the field that some welding joints on the vertical carriage brackets of the tube stand may crack. as a result, the tube arm assembly may exhibit uncharacteristic sideways movement, with the tube becoming off center. if all of the welding joints cracked, the tube arm assembly could fall down and a patient on the examination table or anyone in the vicinity could be struck by the falling tube arm assembly resulting in serious injury or death.
  • Acción
    A Philips Engineer will go on-site and inspect the welding joints of the tube stand vertical carriage brackets and install the safety hooks structure, which will prevent the tube arm assembly from falling down even if all the bracket welding joints are cracked. In the interim, users are to stop using the device.

Device

DuraDiagnost Release 1.0, 2.0, 3.0 X-Ray systems
  • Modelo / Serial
    DuraDiagnost Release 1.0, 2.0, 3.0 X-Ray systemsDuraDiagnost R1.0 Product Number: 712210DuraDiagnost R2.0 and R3.0Product Number: 712211ARTG Number: 207424
  • Clasificación del producto
    Radiology Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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