Events

Rappel de Device Recall CARTOUNIVU MODULE

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
    67505
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1045-2014
  • Date de mise en oeuvre de l'événement
    2014-02-12
  • Date de publication de l'événement
    2014-02-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-05-23
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125603
  • 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 has initiated a recall of the cartounivu module within the carto 3 system (v3.2.2 and v3.2.3) when used with siemens axiom artis vb fluoroscopy systems in particular procedural configurations only. if the table rotation is not returned to zero point, there is a misalignment between the carto 3 system map display and the fluoroscopic capture.
  • Action
    Biosense Webster sent an Urgent Field Safety Notice dated February 12, 2014, to all affected customers to inform them that Biosense Webster has become aware of an issue with a particular configuration of the CartoUnivu Module withn the Carto 3 System (v3.2.2 and v3.2.3) when used with Siemens Axiom Artis VB Fluoroscopy systems in particular procedural configurations only. The letter informs the customers of the problems identified and the actions to be taken. Customers with questions are instructed to contact their Biosense Webster sales representative or cal (866) 473-7823, Monday through Friday from 7am to 8pm EST. Customers with questions about the acknowledgement form and its return, are instructed to call (909) 839-8468. For questions regarding this recall call 909-839-8500.

Device

Device Recall CARTOUNIVU MODULE
  • Modèle / numéro de série
    Serial No. 13201, 11125, 11519, 11320, 11115.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including CA, KY, NJ, MA, and UT and Internationally to Belgium, Austria, and Germany.
  • Description du dispositif
    CartoUnivu Module, Model: Carto 3 Software versions 3.2.2 and 3.2.3; Catalog No. KT-5400-124 || WITH THE CARTOUNIVU MODULE, FLUOROSCOPIC CAPTURES (IMAGES AND CINE CLIPS) CAN BE IMPORTED TO AND DISPLAYED IN THE CART0 3 SYSTEM. THESE IMAGES ARE NOT FOR DIAGNOSTIC PURPOSES. WHEN FLUOROSCOPIC CAPTURES ARE INTEGRATED INTO THE CART0 3 SYSTEM MAP VIEWERS (MAP VIEWER AND ADDITIONAL VIEW), CART0 3 MAPS, MRl OR CT IMAGES, AND CATHETER VISUALIZATION ARE SUPERIMPOSED ON THE FLUOROSCOPIC CAPTURE.
  • 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