Events

Retiro De Equipo (Recall) de MDC PACS Release R2.x and IntelliSpace PACS DCX r3.x (picture archiving and communication 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-2014-RN-00462-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-04-17
  • 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-00462-1
  • 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 a software defect that results in incorrect display of absolute values when measuring pixel density and statistics for region of interest. this issue occurs when enhanced mr and enhanced ct images are sent to the pacs with modality lut (look up tables) as defined in dicom functional group. there could be misdiagnosis if a clinician relies on the incorrect density measurements displayed. this issue does not affect images that are not enhanced image objects.
  • Acción
    Philips is advising their customer that they must configure the MRI and CT devices to send regular CT and MR DICOM image objects (not enhanced) to PACS. Philips is developing a software update to address the issue. This action has been closed-out on 18/02/2016.

Device

MDC PACS Release R2.x and IntelliSpace PACS DCX r3.x (picture archiving and communication system)

Manufacturer

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