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 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
    62342
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1986-2012
  • Date de mise en oeuvre de l'événement
    2012-06-20
  • Date de publication de l'événement
    2012-07-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-08-14
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110296
  • 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
    Defibrillator/monitor cannot analyze an ecg report during acquisition of 12 lead ecg.
  • Action
    Philips Healthcare issued an Urgent Voluntary Medical Device Correction letter on June 20, 2012, to all affected customers. The Notification informs customers of the issue, identifies details (including models and software versions applicable) of units affected, instructions on actions to take while awaiting the correction, and identifies what action Philips plans to eliminate or remedy the issue A Philips Healthcare representative will contact customers to arrange for the updated R.03.03 software installation in all the affected devices. For questions customers were advised to call 1-800-722-9377. For questions regarding this recall call 978-687-1501.

Device

Device Recall Philips Healthcare
  • Modèle / numéro de série
    Serial Numbers: US00558452, US00558453, US00558493, US00558494, US00558539 US00558540, US00558546, US00558547, US00558569, US00558576 US00558584, US00558595, US00558596, US00558597, US00558615 US00558617, US00558618, US00558619, US00558620, US00558621 US00558625, US00558626, US00558627, US00558628, US00558629 US00558630, US00558640, US00558641, US00558642, US00558643 US00558644, US00558779, US00558780, US00558950, US00558952
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including FL, IN, MA, M, NY, OH, TN, TX, and VA. Internationally to AUSTRALIA, HONG KONG, and INDIA
  • Description du dispositif
    Philips HeartStart MRx M3536A Defibrillator/Monitor with Software R.03.03 || 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
    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