Events

Rappel de Device Recall Philips Healthcare IntelliVue Info Center iX, A.0

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Philips Electronics North America Corporation.

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
    72720
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0856-2016
  • Date de mise en oeuvre de l'événement
    2015-11-25
  • Date de publication de l'événement
    2016-02-23
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-09-06
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142024
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
  • Cause
    Reconstructed ecg leads viewed or printed at the information center ix may misrepresent the ecg waveform in specific leads.
  • Action
    Philips Healthcare issued a Field Safety Notice on 11/25/15 to inform customers of the issue, identifies details of the units affected, gives instructions on actions to be taken by the customer and identifies what action Philips plans to take to remedy the issue.Philips will provide a software correction free of charge. On 1/28/16 the Philips issued an updated letter to users.Philips has initiated a correction to address this issue. A software correction will be provided to customers with impacted devices at no charge. Philips is asking customers to follow the Action to be Taken by Customer/User section of the Field Safety Notice: Arrhythmia alarms are not affected. ST alarms, ST values and measurements are also not affected and could be used to assist with the decision to obtain a diagnostic ECG. The ECG waves at the bedside are not affected. Printing ECG waves from the bedside is an alternative to printing from the PIIC iX. If you need any further information or support concerning this issue, contact your local Philips Healthcare Customer Service representative or the Customer Care Solutions Center at (800) 722-9377 with questions or concerns about this Device Correction.

Device

Device Recall Philips Healthcare IntelliVue Info Center iX, A.0
  • Modèle / numéro de série
    Software A.0.X
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-US (nationwide) and the countries of Algeria Australia Austria Belgium Bulgaria Canada Denmark Estonia Finland France Germany Hong Kong Hungary Iceland India Indonesia Iraq Ireland Israel Italy Japan Kenya Korea Kuwait Luxembourg Malaysia Mongolia Morocco Netherlands New Zealand Nigeria Norway Poland Qatar Romania Russian Federation Saudi Arabia Singapore Slovenia South Africa Spain Sweden Switzerland Taiwan Turkey United Arab Emirates and United Kingdom.
  • Description du dispositif
    Philips Healthcare IntelliVue Info Center iX, A.0 866023
  • Manufacturer
    Philips Electronics North America Corporation

Manufacturer

Philips Electronics North America Corporation
  • Adresse du fabricant
    Philips Electronics North America Corporation, 3000 Minuteman Rd, Andover MA 01810-1032
  • Société-mère du fabricant (2017)
    Philips
  • Source
    USFDA