Events

Retiro De Equipo (Recall) de Philips EPIQ 5 Ultrasound System with pediatric cardiology option

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
    18509
  • Fecha de inicio del evento
    2015-05-14
  • 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
    When epiq 5 ultrasound system is set up to 'metric' and weight and/or height is entered, a unit conversion error may result in the incorrect calculation of the patient's body surface area (bsa)., using patient's weight only to calculate the bsa, which is the usual practice for patients under the age of 2 years, would result in a value that is too high by a factor of about 1.7. a cardiac index calculated using that value would be too low by a factor of 1.7. an error of this magnitude may not be readily detected by the user.
  • Acción
    Software to be upgraded

Device

Philips EPIQ 5 Ultrasound System with pediatric cardiology option
  • Modelo / Serial
    Model: EPIQ 5, Affected: , Software version: 1.3.2 or lower with Pediatric Cardiology option
  • Manufacturer
    Philips Ultrasound

Manufacturer

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