Events

Rappel de Philips EPIQ 5 Ultrasound System with pediatric cardiology option

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par Philips Ultrasound.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    18509
  • Date de mise en oeuvre de l'événement
    2015-05-14
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Recalling Organisation: Philips New Zealand Commercial Limited, Level 3, 123 Carlton Gore Road, Newmarket, AUCKLAND 1023
  • Cause
    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.
  • Action
    Software to be upgraded

Device

Philips EPIQ 5 Ultrasound System with pediatric cardiology option
  • Modèle / numéro de série
    Model: EPIQ 5, Affected: , Software version: 1.3.2 or lower with Pediatric Cardiology option
  • Manufacturer
    Philips Ultrasound

Manufacturer

Philips Ultrasound
  • Société-mère du fabricant (2017)
    Philips
  • Source
    NZMMDSA