Events

Rappel de Device Recall Philips HeartStart XL Defibrillator/Monitor

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
    64201
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0871-2013
  • Date de mise en oeuvre de l'événement
    2013-01-28
  • Date de publication de l'événement
    2013-02-21
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115542
  • 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
    Philips heartstart xl+ defibrillator/monitor may become locked out of clinical use.
  • Action
    Philips Healthcare sent an Urgent Medical Device Recall letter dated January 2013 on January 28, 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised if the Philips HeartStart XL+ Defibrillator/Monitor is first powered on and then there is disconnection or an interruption in AC power, the device may be locked out of clinical mode until the user enters the service mode password and performs an Operational Check. Users are provided with the Safety Notice that provides information on how to identify affected devices and instructions on actions to be taken. Customers were advised to follow the ACTION TO BE TAKEN BY CUSTOMER / USER section of the notice. To correct this issue Philips will provide a software upgrade to customers with affected units free of charge. If you need any further information or support concerning this issue, please contact your local Philips representative at 1-800-722-9377. For questions regarding this recall call 978-687-1501.

Device

Device Recall Philips HeartStart XL Defibrillator/Monitor
  • Modèle / numéro de série
    Serial number range: USO1100100 - USO1100372,  USN1100376 - USN1100960, USD1100961 - USD1101095,  US11201096 - US11201186,  US21201187 - US21201239,  US31201240 - US31201537,  US41201538 - US41201585,  US51201586 - US51201721,  US61201722 -US61201924,  US71201925 - US71202048,  US81202049 - US81202168, US91202169- US91202514,  USO1202515 - USO1202990,  USN1202991 - USN1203537,  USD1203538- USD1203968,  US11303969 - US11303972
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to ALGERIA, ANGOLA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BULGARIA, COLOMBIA, CROATIA (LOCAL NAME HYVATSKA), CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, EGYPT, ESTONIA, FINLAND, FRANCE, GABON, GERMANY, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAN (ISLAMIC REPUBLIC OF), IRAQ, IRELAND, ISRAEL, ITALY, JORDAN, KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, MALAYSIA, MALTA, MAURITIUS, MOROCCO, NAMIBIA, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, PALESTINE, POLAND, PORTUGAL, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA (SLOVAK REPUBLIC), SLOVENIA, SOUTH AFRICA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, SYRIAN ARAB REPUBLIC, TANZANIA, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, AND VIET NAM.
  • Description du dispositif
    Philips HeartStart XL+ Defibrillator/Monitor || Model number: 861290 || The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced life support or defibrillation
  • 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