Events

Retiro De Equipo (Recall) de EPIQ 7 Diagnostic Ultrasound System (software version 1.0, 1.0.1)

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-01085-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-10-22
  • 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-01085-1
  • 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
    Under system settings, if the system date format is set to international, dd/mm/yyyy, the system continues to interpret the date as mm/dd/yyyy on the patient data entry (pde) screen. the anomaly exists in date fields for ‘last menstrual period’ (lmp), ‘established due date’ (edd) and ‘conception date’. the lmp field is presented in four exam types: obstetric (ob,) fetal echo, gynaecology (gyn), and breast and populates from one exam type to the other.
  • Acción
    Philips is advising users that the issue can be avoided by making sure the system is set to the default setting of MM/DD/YYYY. A Philips Field Service Engineer will contact customers to schedule a software update to correct the issue.

Device

EPIQ 7 Diagnostic Ultrasound System (software version 1.0, 1.0.1)

Manufacturer

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