Events

Retiro De Equipo (Recall) de Brilliance iCT and Brilliance iCT SP with software versions 4.1.0.xxxxx, or 4.1.1.xxxxx, or 4.1.2.xxxxx

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-2015-RN-00068-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-01-28
  • 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-2015-RN-00068-1
  • 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 identified a software defect that may result in the scanner updating the planned scan length to be longer than the user intended. this may happen if:1. the exam is planned with low pitch and rotation time values, for example, 0.3 pitch and 0.27 rotation time, and2. the plan scan length is increased or lengthened on the surview/scout, and3. the system displays a pop-up message that the current pitch, rotation time, and planned scan length are incompatible and suggests a new pitch and rotation time. 4. if the user accepts the suggested pitch and rotation time changes, the system adjusts the plan to the maximum allowed scan length, which will plan the study beyond the original intended length.
  • Acción
    Philips is providing instruction to assist identify if a system is affected and advising end users to ensure that the scan length is verified prior to initiating the scan. A Philips Field Service Engineer will contact affected customers to arrange for the software to be updated. This action has been closed-out on 19/07/2016.

Device

Brilliance iCT and Brilliance iCT SP with software versions 4.1.0.xxxxx, or 4.1.1.xxxxx, or 4.1.2...
  • Modelo / Serial
    Brilliance iCT and Brilliance iCT SP with software versions 4.1.0.xxxxx, or 4.1.1.xxxxx, or 4.1.2.xxxxxARTG Number: 98868
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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