BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-1045-2014 · Initiated February 12, 2014

    Recall

    Recall Number
    Z-1045-2014
    Event Number
    67505
    Firm
    Biosense Webster, Inc.
    FEI Number
    3003113629
    Product Code
    DQK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 12, 2014
    Posted
    February 20, 2014
    Terminated
    May 23, 2014
    Address
    15715 Arrow Hwy, Irwindale, CA, 91706-2006

    Description

    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.

    Reason

    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.

    Distribution

    Worldwide Distribution - USA including CA, KY, NJ, MA, and UT and Internationally to Belgium, Austria, and Germany.

    Quantity

    8 units total (5 units in US)