BEUDAMED
    FDA Enforcement Class II Terminated

    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.

    Recall: Z-2776-2016 · Reported September 21, 2016

    Enforcement

    Recall Number
    Z-2776-2016
    Event ID
    75012
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biosense Webster, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 21, 2016
    Initiation Date
    August 15, 2016
    Classification Date
    September 9, 2016
    Termination Date
    January 20, 2017
    Address
    15715 Arrow Hwy, N/A, Irwindale, CA, 91706-2006, United States

    Description

    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.

    Reason

    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).

    Code Info

    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

    Distribution

    International Distribution to China, Hong Kong and Brazil.

    Quantity

    338 units