Events

Rappel de SureSigns VSi, VS2+ products

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-00177-2
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2018-02-27
  • 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-00177-2
  • 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
    Phillip has identified that certain suresigns vsi, vs2+ products labels have a printing error on the date of manufacture.This action supersedes rc-2017-rn-01263-1 regarding an error in printing of the date of manufacture on the same devices.
  • Action
    Philips is advising that the affected products may continue to be used because this Date of Manufacture information on the serial number label, does not impact any of device function or operation. Philips will provide a new label with no printing error for the Date of Manufacture for each affected unit. An instruction will be provided to the impacted customers on how to perform the correction. A Philips Healthcare representative will contact users to arrange for the correction.

Device

SureSigns VSi, VS2+ products
  • Modèle / numéro de série
    SureSigns VSi, VS2+ products All devices manufactured between December 15, 2016 and May 02, 2017Model: SureSigns VSi - NBPProduct: 863275Model: SureSigns VSi - NBP/SPO2Product: 863276Model: SureSigns VS2+ NBP/SPO2Product: 863278Multiple affected serial numbersARTG: 93971Philips Electronics Australia Patient monitor, multiparameter
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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