Events

Rappel de Carto 3 EP Navigation System

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 Biosense Webster, 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
    72167
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0002-2016
  • Date de mise en oeuvre de l'événement
    2015-09-10
  • Date de publication de l'événement
    2015-10-01
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-05-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140077
  • 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
    Image disappeared from the cardiac ultrasound system when the carto 3 ep navigation system needed restarting while the patient was experiencing pericardial effusion. affects the cartosound module of the carto 3 ep navigation system when used with the soundstar eco 8f and 10f diagnostic ultrasound catheters. new precautions added.
  • Action
    A Customer Notification Letter and Acknowledgement Form was distributed to customers on 09/10/15. One letter and form was sent via express mail, addressed to the Risk Management Office and one additional letter and form was sent by the firm's account representative to the Electrophysiology (EP/Cardiology Lab directly at the customer site. The firm's notification letter stated that they want to emphasize the following statement "The intra-cardiac ultrasound image will disappear if the CARTO 3 EP Navigation System power is disrupted and this may present a safety issue if the EP is using the ultrasound to monitor the patien during EP procedure. The ultrasound image will not reappear until the CARTO 3 System is restored." The firm will be updating the product labeling to further reinforce the precautionary statement. The firm requests that customers take the following actions: 1. Read the Field Safety Notification carefully. 2. Pass on this notification to anyone in the facility that needs to be informed of this issue, including appropriate clinical personnel involved in the use of SOUNDSTAR¿ eco Catheters. 3. Review, complete, sign and return the attached Acknowledgement Form in accordance with the instructions on the form. 4. Maintain a copy of this letter with the product. 5. Maintain awareness of the Field Safety Notification For any questions the firm states to contact the BWI sales representative.

Device

Carto 3 EP Navigation System
  • Modèle / numéro de série
    Catalog #: C3SOUND, 10439236, 10439072, 10439011, 10438577
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution. US nationwide, Italy, Canada, Japan, China, Singapore, Colombia, England, Russia, Spain, France, Germany, Finland, Ireland, Australia, Sweden, Hungary, India, Brazil, Slovenia, Netherlands, Mexico, and South Africa.
  • Description du dispositif
    Carto 3 EP Navigation System. Electro physiology system which views of the electrical activity of the heart through real-time data on 3-D, color-coded cardiac maps.
  • Manufacturer
    Biosense Webster, Inc.

Manufacturer

Biosense Webster, Inc.
  • Adresse du fabricant
    Biosense Webster, Inc., 15715 Arrow Hwy, Irwindale CA 91706-2006
  • Société-mère du fabricant (2017)
    Johnson & Johnson
  • Source
    USFDA