Events

Rappel de Device Recall Philips AudioVideo Engineering PAS210 Remote Active Speakers Kit

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 Healthcare 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
    58667
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2217-2011
  • Date de mise en oeuvre de l'événement
    2011-05-03
  • Date de publication de l'événement
    2011-05-19
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-04-25
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99864
  • 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
    Pas-210 kit remote active speaker assembly used with the intellivue information centerspeaker cable connection may lead to intermittent or loss of audio alarm annunciation.
  • Action
    Philips Healthcare issued an Urgent - Medical Device Correction letter dated April 28, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to follow the "Action to be taken by Customer/User" section of the instructions while they await the correction, which will likely come in the form of a replacement audio cable for all affected speaker assemblies. For further information or support concerning this issue, please contact Philips Healthcare Customer Care Service Center at 800-722-9377 # 3, # 1 and reference the letter or your local Philips representative in your area.

Device

Device Recall Philips AudioVideo Engineering PAS210 Remote Active Speakers Kit
  • Modèle / numéro de série
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the country of Canada
  • Description du dispositif
    Philips Audio-Video Engineering PAS-210 Remote Active Speakers Kit used with the IntelliVue Information Center || The intended use of the Information Center Software is to display physiologic waves, parameters and trends, formal data for strip recordings and printed reports and provide the secondary annunciation of alarms from other networked medical devices at a centralized location. The Information Center Software provides for the retrospective review of alarms, physiologic waves and parameters from its database. An additional intended use is to provide primary annunciation of alarms and configuration and control access for networked telemetry monitors.
  • Manufacturer
    Philips Healthcare Inc.

Manufacturer

Philips Healthcare Inc.
  • Adresse du fabricant
    Philips Healthcare Inc., 3000 Minuteman Road, Andover MA 01810
  • Société-mère du fabricant (2017)
    Philips
  • Source
    USFDA