Events

Retiro De Equipo (Recall) de Philips EPIQ 7 Ultrasound System

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Philips Ultrasound.

¿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
    15551
  • Fecha de inicio del evento
    2013-10-22
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Philips New Zealand Commercial Limited, Level 3, 123 Carlton Gore Road, Newmarket, AUCKLAND 1023
  • 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, gynecology (gyn), and breast and populates from one exam type to the other.
  • Acción
    Software to be upgraded

Device

Philips EPIQ 7 Ultrasound System
  • Modelo / Serial
    Model: Model: EPIQ 7, Affected: Software version 1.0 and 1.0.1
  • Manufacturer
    Philips Ultrasound

Manufacturer

Philips Ultrasound
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    NZMMDSA