Events

Rappel de Philips Heartstart HS1 Home

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.

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
    55579
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1917-2010
  • Date de mise en oeuvre de l'événement
    2010-04-30
  • Date de publication de l'événement
    2010-06-28
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-12-10
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91632
  • 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 Defibrillator - Product Code MKJ
  • Cause
    Seventeen aeds failed production line testing (final acceptance test).
  • Action
    The firm notified U.S. distributors on 4/30/2010 via phone call and e-mail to obtain consignee location information. A website providing information was activated on 4/30/2010. On 5/3/2010 Urgent Medical Device Recall letters, dated April 29, 2010 were sent to direct customers in the US. The letters explained the reason for the recall and Customers were asked to verify that they have the product subject to recall. Replacement AEDs will be provided at no charge to the customer. Field Safety Notices were attached to the letters and provided a list of actions for customers to take. Customers should check the serial number on their devices against the list provided, contact Philips Healthcare to arrange for replacement, and ensure that necessary staff are aware of the recall. For further information and support, Philips Healthcare should be contacted at 1-800-263-3342.

Device

Philips Heartstart HS1 Home
  • Modèle / numéro de série
    SERIAL NUMBERS--MODEL M5068A: A10C-05951.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA, Canada, Japan, United Arab Emirates, Austria, Switzerland, Germany, Spain, France, Italy, and Norway.
  • Description du dispositif
    Automated External Defibrillator (AED) of brand name "Philips HeartStart HS1 Home" (Model Number M5068A). || Device is designed for use on a person in sudden cardiac arrest who is unresponsive when shaken and not breathing normally
  • Manufacturer
    Philips Medical Systems

Manufacturer

Philips Medical Systems
  • Adresse du fabricant
    Philips Medical Systems, 2301 5th Ave Ste 200, Seattle WA 98121
  • Source
    USFDA