Retiro De Equipo (Recall) de Ingenuity TF PET/CT

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
  • ID del evento
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Three issues were identified that may cause a situation requiring a patient rescan:1. after a surview and low dose ct scan, the system does not show the "enable" button prompt to allow the user to begin the pet scan resulting in the inability to perform the pet scan.2. when navigating to the series field value within the scan parameters pane, the series field value will accept certain characters resulting in the failure of the system to properly process the data and provide a reconstructed image.3. a pet reconstruction failure as a result of an incomplete study.
  • Acción
    Philips Healthcare will be installing a software update v 4.0.3. Until software is upgraded, Philips Healthcare advises users to perform workarounds identified in letter.


  • Modelo / Serial
    Ingenuity TF PET/CTModel number 882456 Software version: 04-Jan-2013Serial numbers: 2004, 2005, 2006, 2007, 2008, 2009, 2010, 2011, 2012, 2013, 2015, 2016, 2017, 2018, 2019ARTG number: 118077
  • Manufacturer


  • Empresa matriz del fabricante (2017)
  • Source