Events

Rappel de Philips IntelliVue Information Centre (PIIC) iX

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 Medical Systems (USA).

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
    18025
  • Date de mise en oeuvre de l'événement
    2015-01-26
  • 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
    Sp02 and/or non invasive blood pressure (nbp) alarms may become disabled without visual notification to the user., a software defect has been identified that involves the use of the "change bed label" feature at the information center ix. if the configuration for this item is set to "optional" and a user selects the "location" button within the "manage patient" menu and makes a change to the patient location, alarms for sp02 and/or non invasive blood pressure (nbp) will become disabled without visual notification (bell with an "x") to the user. this problem only happens when the patient is monitored using a networked intellivue trx telemetry m4841/trx4851a patient worn device (pwd).
  • Action
    Software to be upgraded

Device

Philips IntelliVue Information Centre (PIIC) iX
  • Modèle / numéro de série
    Model: Part Numbers: 866023, 866024, 866117, Affected: , Software version: Revisions A.00, A.01, A.02
  • Manufacturer
    Philips Medical Systems (USA)

Manufacturer

Philips Medical Systems (USA)
  • Société-mère du fabricant (2017)
    Philips
  • Source
    NZMMDSA