Events

Rappel de Device Recall Philips Healthcare

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 Medical Systems, 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
    67857
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1439-2014
  • Date de mise en oeuvre de l'événement
    2014-03-31
  • Date de publication de l'événement
    2014-04-09
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-10-21
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126503
  • 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
    Automated external defibrillators (non-wearable) - Product Code MKJ
  • Cause
    A component on the heartstart xl+ therapy board could malfunction potentially affecting the ability to deliver therapy.
  • Action
    Philips Healthcare issued an Urgent-Medical Device Correction letter dated March 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. This Field Safety Notice is intended to inform you about: " what the problem is and under what circumstances it can occur " the actions that should be taken by the customer/user in order to prevent risks for patients or users " the actions planned by Philips to correct the problem. A component on the HeartStart XL+ Therapy Board could malfunction potentially affecting the ability to deliver therapy. Please see the attached Field Safety Notice that provides information on how to identify affected devices and instructions on actions to be taken. Please follow the ACTION TO BE TAKEN BY CUSTOMER / USER section of the notice. To correct this issue Philips will provide a replacement therapy board to customers with affected units free of charge. This voluntary correction has been reported to the appropriate regulatory agencies. If you need any further information or support concerning this issue, please contact your local Philips representative at Philips representative contact details to be completed by the KM / country. Philips apologizes for any inconveniences caused by this problem. Further questions please call (978) 687-1501.

Device

Device Recall Philips Healthcare
  • Modèle / numéro de série
    Serial Numbers: USN1307680 USD1309181 USD1308456 USD1309182 USD1309167 USD1309184 USD1309168 USD1309194 USD1309180 USD1309195 USD1309196 USD1309274 USD1309197 USD1309286 USD1309227 USD1309301 USD1309264 US11409686 USD1309269
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Distribution including the states of IN and WA., and the countries of : CHINA FRANCE GERMANY ITALY MALAYSIA PANAMA SAUDI ARABIA TURKEY and UNITED KINGDOM.
  • Description du dispositif
    Philips HeartStart XL+ Defibrillator/Monitor || Model number: 861290, automatic external defibrillator.
  • Manufacturer
    Philips Medical Systems, Inc.

Manufacturer

Philips Medical Systems, Inc.
  • Adresse du fabricant
    Philips Medical Systems, Inc., 3000 Minuteman Rd, Andover MA 01810-1032
  • Société-mère du fabricant (2017)
    Philips
  • Source
    USFDA