Events

Rappel de Welch Allyn Propaq LT/ Propaq 802 Patient Monitor

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 Welch Allyn Protocol Inc.

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
    15629
  • Date de mise en oeuvre de l'événement
    2013-11-15
  • 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: Medxus Ltd, Unit 4, 100 Fitgerald Avenue, Christchurch 8011
  • Cause
    Internal serial testing has identified fault conditions relating to hardware or software failure or electrical noise caused by proximal defibrillation activity that could, in rare instances, potentially interrupt propaq lt device operations. if this were to occur the device would either present an error screen instructing the user to restart the monitor, or could present a blank screen or white screen.Either screen would be accompanied by one or more blimking led lights, and in either case, the isue would be resolved by restarting (power cycling) the monitor.
  • Action
    Software to be upgraded

Device

Welch Allyn Propaq LT/ Propaq 802 Patient Monitor

Manufacturer

Welch Allyn Protocol Inc