Events

Retiro De Equipo (Recall) de EPIQ 7 Ultrasound system version 1.0 (Intended for diagnostic ultrasound imagingand fluid flow analysis)

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-01011-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-09-25
  • 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-01011-1
  • 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 problem has been detected with philips model epiq 7 ultrasound system v1.0 when using philips qlab a2dq software feature. it is possible to have erroneous ejection fraction (ef) measurements appear in the biplane analysis report page under certain conditions while using a2dq. the biplane analysis report page could display ap2 or ap4 edv/esv/ef measurements from a prior patient’s exam. erroneous measurement information in the biplane analysis report page could mistakenly influence patient care. this issue only occurs on software version 1.0 in a2dq during a live (frozen) image and only when a single biplane view is included in the exam. when both biplane views are present (ap2 and ap4) this issue does not occur.
  • Acción
    Philips corrected this issue in Version 1.01 of the EPIQ 7 Ultrasound System. A Philips Field Service Engineer will be contacting customers to schedule the V1.01 upgrade to affected systems. Philips is providing temporary workaround instructions to prevent the failure mode from occurring until the systems are upgraded.

Device

EPIQ 7 Ultrasound system version 1.0 (Intended for diagnostic ultrasound imagingand fluid flow an...
  • Modelo / Serial
    EPIQ 7 Ultrasound system version 1.0 (Intended for diagnostic ultrasound imagingand fluid flow analysis)ARTG Number: 93851
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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