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
    75012
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2776-2016
  • Date de mise en oeuvre de l'événement
    2016-08-15
  • Date de publication de l'événement
    2016-09-09
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-01-20
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149112
  • 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
    Biosense webster, inc. is initiating a voluntary correction to re-install identified carto 3 systems that were moved and installed in china without testing and approval by biosense webster technical services, as described in the instructions for use (ifu).
  • Action
    Biosense Webster sent a Customer Notification letter dated August 23, 2016, to all affected customers to inform them that Biosense Webster, Inc. recently became aware that some systems were improperly transported and installed at hospitals in China by Biosense Webster, Inc. Clinical Specialists. The letter informs the customers that according to the CARTO 3 System Instructions for Use (IFU), only the Biosense Webster, Inc. Technical Services team members are authorized to properly install the systems. Customers are informed that each impacted CARTO 3 System must be fully tested and approved by the Biosense Webster, Inc.Technical Services Team. The letter informs the customers of the actions to be taken. Actions Requested on Your Part: 1. Read this Medical Device Correction notification carefully. 2. If a CARTO¿ 3 System currently resides within your hospital, the system has been corrected, and you should ensure that you have received a Field Service Report that indicates the system is in order. For questions regarding this recall call 909-839-8500. 3. Review, complete, sign, and return the Acknowledgement Form in accordance with the instructions listed on the form. 4. In the future, if a CARTO¿ 3 System is installed in your facility, you should only conduct a clinical procedure after you have received a Field Safety Report dated after the installation of the device indicating that the system is in order. 5. Maintain awareness of this notice and pass this notice on to anyone in your facility that needs to be informed. Customers with any questions are instructed to contact their Biosense Webster, Inc. sales representative.

Device

CARTO 3 EP Navigation System
  • Modèle / numéro de série
    V 3.2: 2258, 10284, 10332, 10345, 11640, 11642, 60011, 60012, 60606, 60611, 60613, 60618, 60621, 60625, 60634, 60644, 60651, 60654, 60657, 60658, 60660, 60661, 60664, 60671, 60673, 60674, 60680, 60682, 60683, 61000, 61002, 61005, 61010, 61014, 61038, 61039, 61041, 61045, 61046, 61050, 61055, 61060, 61062, 61064, 61071, 61501, 66114, 66115, 66117, 66118, 66119, 29306, 13173, 13213, 11567, 14528  V 4.3: 61053, 61054, 61059, 11701, 12664  V 2.3: 14218, 13208, 50203, 50531, 14718, 50573
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    International Distribution to China, Hong Kong and Brazil.
  • Description du dispositif
    CARTO 3 EP Navigation System and Accessories, Product Codes: FG540000 and FG540000C, Software Versions: v 3.2 , v 4.3 and v 2.3. || The CARTO 3 EP Navigation System is intended to be used in catheter-based cardiac electrophysiological (EP) procedures. The CARTO 3 System provides information about the electrical activity of the heart and catheter location during the procedure.
  • 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