Events

Rappel de Device Recall Philips

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
    77437
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2528-2017
  • Date de mise en oeuvre de l'événement
    2010-12-17
  • Date de publication de l'événement
    2017-06-13
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-08-01
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=156055
  • 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
    Potential for early component failure.
  • Action
    Philips sent an Urgent Medical Device Correction letter dated December 17, 2010, to all affected consignees. Philips will replace defective system boards in Hewlett Packard model rp5700 PCs sold with IntelliVue Information Centers to correct the problem. Philips Healthcare representatives will inspect all affected units, and any unit identified to have a defective system board will have its system board replaced at no charge to the customer. Philips is asking the following of customers in the Action to be Taken by Customer/User section of the FSN: Observe your system for any of the symptoms described in the Problem Description section above. If symptoms are noted, please contact your local Philips Healthcare Customer Service representative or the Customer Care Solutions Center at (800) 722-9377 # 3, # 1. Do not rely exclusively on the audible alarm system for patient monitoring. Remember that the most reliable method of patient monitoring combines close personal surveillance with correct operation of monitoring equipment. For questions regarding this recall call 978-659-3000.

Device

Device Recall Philips
  • Modèle / numéro de série
    This action affects certain customers who were shipped an affected Philips Intellivue Information Center unit between June 9, 2008 and May 31, 2009. Affected products have a PC serial number range between 2UA8300XYZ and 2UA84510QW. However, only a subset of these products are affected.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US (Nationwide) OUS: CANADA ARGENTINA AUSTRALIA AUSTRIA BAHRAIN BELGIUM BRAZIL CHILE CHINA COLOMBIA CZECH REPUBLIC FINLAND FRANCE GERMANY GREECE INDIA INDONESIA IRELAND ITALY JAPAN KENYA KOREA, REPUBLIC OF NETHERLANDS PHILIPPINES POLAND SPAIN SWEDEN SWITZERLAND THAILAND TURKEY UNITED KINGDOM
  • Description du dispositif
    M3150 Information Center Local Database; Models: 862249, 865001, 865003, 865004, 865007, 865009, 865011, 865012, 865091, 865092, 865093, 865094, 865095, 865096, 865098, 865099, 865102, 865104, 865105, 865125, 865127. || 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 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