Events

Retiro De Equipo (Recall) de Philips Brilliance 64 and Ingenuity CT/Core/Core128 with software versions 4.1.6.XX030 or 4.1.6.XX032

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-01528-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-11-23
  • 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-01528-1
  • 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
    A complaint was received by philips indicating that the non-gated bolus tracking clinical scan failed to initialise with the system displaying the error message:“a problem has occurred; please retry. if the problem persists contact service.” this resulted in the study being cancelled with a loss of bolus. if this were to re-occur, it may necessitate a rescan.
  • Acción
    Philips Healthcare will be installing a software update to correct the issue. A Philips Field Service Engineer will contact affected customers to schedule the software update installation at their site. In the interim, customers are advised that when failure occurs the users may : 1. Continue initiating the diagnostic scan manually. 2. Repeat the bolus tracker scan Customers are also advised to use one of the workaround options provided in the customer letter to prevent the failure of non-gated Bolus Tracking clinical scans with dose modulation.

Device

Philips Brilliance 64 and Ingenuity CT/Core/Core128 with software versions 4.1.6.XX030 or 4.1.6.X...
  • Modelo / Serial
    Philips Brilliance 64 and Ingenuity CT/Core/Core128 with software versions 4.1.6.XX030 or 4.1.6.XX032ARTG Number: 98868
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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