Events

Retiro De Equipo (Recall) de Ingenuity CT, Ingenuity Core, Ingenuity Core128 with Continuous Computed Tomography (CCT) Option and have been upgraded from Software Version 3.x to Version 4.0.0 / 4.0.1

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-2014-RN-01100-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-10-10
  • 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-2014-RN-01100-1
  • 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 became aware through a customer complaint that while performing a cct examination on an ingenuity ct system, the first image was marked as “last shot” rather than the actual “last shot” acquired. after the clinician pressed the pedal for first exposure, images were displayed as the “last shot”. subsequent pedal presses did not result in immediate image reconstruction and the first image remained on the screen labelled as the “last shot”. eventually all images appeared. during an interventional procedure, there is a risk of serious injury to the patient if the clinician does not have real-time feedback of needle placement when the needle is near vital structures (major blood vessel, organ, etc).
  • Acción
    Philips is advising that affected users should check their CCT exam card and correct if the issue exists as described in the instructions supplied with the customer letter. A Philips Field Service Engineer will contact customers to schedule the software update at their site to permanently correct the issue. This action has been closed-out on 05/09/2016.

Device

Ingenuity CT, Ingenuity Core, Ingenuity Core128 with Continuous Computed Tomography (CCT) Option ...
  • Modelo / Serial
    Ingenuity CT, Ingenuity Core, Ingenuity Core128 with Continuous Computed Tomography (CCT) Option and have been upgraded from Software Version 3.x to Version 4.0.0 / 4.0.1ARTG number: 98868
  • Clasificación del producto
    Radiology Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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