Rappel de Device Recall Philips Medical HeartStart MRx 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
    54892
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1317-2010
  • Date de mise en oeuvre de l'événement
    2010-03-04
  • Date de publication de l'événement
    2010-04-09
  • Statut de l'événement
    Terminated
  • Pays de l'événement
  • Date de fin de l'événement
    2017-02-15
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
  • 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
    Defibrillator Monitor - Product Code MKJ
  • Cause
    Batteries older than 2 years have a higher potential for intermittent electrical contact, may contribute to an interruption in monitoring or therapy if the monitor/defibrillator is operating on battery.
  • Action
    An "Urgent Medical Device Correction" letter with a Field Safety Notice was issued on March 4, 2010 to affected customers. The Instructions for Use Addendum/Application Note is included with the communication describing when to replace the unit's 14.8-Volt Lithium Ion Battery (Product #M3538A) Number M3538A in the the Philips HeartStart MRx Monitor/Defibrillator. Should you have any questions or concerns about the Device Correction, please contact your local Philips representative.

Device

  • Modèle / numéro de série
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  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide: UNITED STATES, CANADA, AFGHANISTAN, ALBANIA, ,ARGENTINA, ARUBA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELGIUM BOSNIA&HERZEGOVINA;, BRAZIL, BRUNEI DARUSSALAM, BULGARIA, CHILE, CHINA, COLOMBIA, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, ESTONIA, FINLAND, FRANCE, FRANCE, GERMANY, GREECE, GUADELOUPE, HONG KONG, ICELAND, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KENYA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRI, LITHUANIA, LUXEMBOURG, MALAYSIA, MEXICO, NAMIBIA, NETHERLANDS, NETHERLANDS ANTILLES, NETHERLANDS ANTILLES, NEW CALEDONIA, NEW ZEALAND, NICARAGUA, NORWAY, OMAN, PAKISTAN, PALAU, PANAMA, PAPUA NEW GUINEA, PERU, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO, QATAR, REUNION, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, UGANDA, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, VIETNAM and YEMEN.
  • Description du dispositif
    HeartStart MRx Defibrillator Monitor (Models M3535A, M3536A and M3536J) used with Philips 14.8-Volt Lithium Ion Battery (ModeI M3538A). || The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.
  • Manufacturer

Manufacturer

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