Events

Retiro De Equipo (Recall) de Allura Xper R8.2 and UNIQ R1.0 X-Ray Systems (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-00881-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2016-07-01
  • 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-2016-RN-00881-1
  • 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 healthcare has identified through trend analysis an increase in the failure rate of certain low-voltage dc power supplies (“dcps”) used in the affected products. each system contains multiple dcps, some of which may be subject to an increased probability of failure. failure of a dcps may result in the sudden loss of imaging functionality or mechanical movement, depending on what subsystems the dcps is powering. the likelihood of a system failure to occur is remote.The loss of key imaging functionality or mechanical movement during a diagnostic or therapeutic procedure may interrupt or require the abandonment of the procedure. in rare instances, unavailability of live imaging might lead to a possible injury to the patient when the system fails during a critical phase of the procedure.
  • Acción
    Philips will replace the affected DCPS. Philips Healthcare service representative will contact customers with affected devices to arrange for the service. In the interim, the users are recommended to follow their pre-established procedures for managing potential patient safety in the event that the system shuts down.

Device

Allura Xper R8.2 and UNIQ R1.0 X-Ray Systems (diagnostic, fluoroscopic x-ray system)
  • Modelo / Serial
    Allura Xper R8.2 and UNIQ R1.0 X-Ray Systems (diagnostic, fluoroscopic x-ray system)All Allura Xper R8.2 systems are affected and the following have been identified in Australia:Allura Xper FD10, 722026Allura Xper FD10/10, 722027Allura Xper FD20, 722028Allura Xper FD20 OR Table, 722035Allura Xper FD20/20 biplane OR Table, 722039Allura Xper FD20/15, 722058ARTG Number: 175708
  • Clasificación del producto
    Radiology Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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