Events

Rappel de CardioTek EPTracer

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 CardioTek BV.

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
    77025
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2657-2017
  • Date de mise en oeuvre de l'événement
    2017-04-13
  • 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=154842
  • 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
    Computer, diagnostic, programmable - Product Code DQK
  • Cause
    Software bug which allows parameters to be changed unintentionally during use.
  • Action
    The Firm, Schwarzer cardiotek, sent an "Urgent Field Safety Notice" dated 4/21/2017 to its consignees. The notice described the product, problem and actions to be taken. The consignees were instructed to do the following: " While backup pacing is active the software must not be operated. " In case of backup pacing disconnect all catheter connection pins and reconnect only the two required for stimulation to the dedicated backup pacing output ports (OUT1 or OUT2). " If the backup pacing parameters were changed by accident quickly switch backup pacing off and on again to reset the parameters. " Ensure that the system is only operated by trained users. The firm plans to do the following: " provide an amendment to the hardware manual concerning the correct use of the backup pacing functionality to all service partners and customers. An updated software, which prevents accidental change of backup pacing parameters will be made available. Upon receipt of the amendment and installation of the software update, the completed feedback form must be returned to CardioTek no later than 3/4/2018 by fax +49 7131 2774 590 or email: Service@schwarzercardiotek.com. If you have any questions, please contact Sales & Service at +49 172 790 9112 or email: Service@schwarzercardiotek.com.

Device

CardioTek EPTracer
  • Modèle / numéro de série
    All EP-Tracer -FSCA-identifier (2017-04-06)
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) to states of: CA, IL, OH, and MN; and countries of: Albania, Algeria, Argentina, Bangladesh, Belgium, Bolivia, Brazil, Canada, Chile, Colombia, Costa Rica, Croatia, Cuba, Czech Rep, Denmark, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Guatemala, Honduras, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Jordan, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Malaysia, Malta, Mexico, Monaco, Morocco, Netherlands, Norway, Pakistan, Palestine, Peru, Philippines, Poland, Portugal, Rep. Dominicana, Romania, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syria, Trinidad & Tobago, Turkey, United Arab Emirates, United Kingdom, Venezuela and Vietnam.
  • Description du dispositif
    CardioTek EP-TRACER Software V1.x and V2.0 || The EP-TRACER System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record signals obtained during electrophysiological studies and related procedures. The system allows the user to monitor, display and record the signals. The system incorporates a stimulator intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart.
  • Manufacturer
    CardioTek BV

Manufacturer

CardioTek BV
  • Adresse du fabricant
    CardioTek BV, Amerikalaan 70, Maastricht-Airport Netherlands
  • Source
    USFDA