Events

Rappel de Philips IntelliVue Information Center (PIIC) iXAll PIIC iX Surveillance stations including:866023 IntelliVue Info Center iX A.0866117 PIIC Classic Upgrade 866389 IntelliVue Info Center iX B.0, C.0867141 IntelliVue Info Center iX B.0

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Philips Electronics Australia Ltd.

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
    RC-2018-RN-00026-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-01-05
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00026-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notes supplémentaires dans les données
  • Cause
    Philips has been made aware of a potential problem with all piic ix surveillance and patient link revisions. the issue will occur after a surveillance station is first restarted during the year 2018. after that initial restart, the station will thereafter no longer perform patient discharge and transfer operations. any subsequent attempt to perform these operations will cause the station to restart, resulting in a short period of loss of monitoring at the surveillance station during such restart.
  • Action
    Philips is advising users that in order to avoid this issue, do not intentionally restart any surveillance stations that have been running normally since the new year. Users may use the workflows described in the attachment provided with the customer letter to avoid operations that may cause the surveillance station to restart. When a patient is discharged, confirm that the patient is discharged.

Device

Philips IntelliVue Information Center (PIIC) iXAll PIIC iX Surveillance stations including:866023...
  • Modèle / numéro de série
    Philips IntelliVue Information Center (PIIC) iXAll PIIC iX Surveillance stations including:866023 IntelliVue Info Center iX A.0866117 PIIC Classic Upgrade 866389 IntelliVue Info Center iX B.0, C.0867141 IntelliVue Info Center iX B.0ARTG 94237
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

Philips Electronics Australia Ltd
  • Société-mère du fabricant (2017)
    Philips
  • Source
    DHTGA