Events

Retiro De Equipo (Recall) de MDC PACS R2.3 SP2 HF6 and MDC PACS R2.3 SP2 HF7 (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-2013-RN-01110-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-10-29
  • 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-2013-RN-01110-1
  • 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 software error exists that changes the study time sent from modalities when it ends in zero(es) and incorrectly displays it in the pacs work list. the result is that examinations are displayed with a study time of 00:00:00 or 24:00:00 instead of the actual time the study was taken at, resulting in the chronological order of these exams being incorrectly displayed. this incorrect display of study time/ incorrect chronological order may result in patient misdiagnosis.
  • Acción
    Philips is advising users to rely on the study time displayed in DiagNET viewer and not in the PACS client worklist in case studies acquired on the same date. A software update will be provided to permanently correct the issue.

Device

MDC PACS R2.3 SP2 HF6 and MDC PACS R2.3 SP2 HF7 (Picture, archiving and communication system)
  • Modelo / Serial
    MDC PACS R2.3 SP2 HF6 and MDC PACS R2.3 SP2 HF7 (Picture, archiving and communication system)Serial Number: MCD121100431ARTG Number: 207252
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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