BEUDAMED
    FDA Recall Terminated

    Belos VR Implantable Cardioverter Defibrillator (ICD) with version A-K00.1.U/1 programmer software.

    Recall: Z-0076-04 · Initiated September 24, 2003

    Recall

    Recall Number
    Z-0076-04
    Event Number
    27418
    Firm
    Biotronik Inc
    FEI Number
    1028232
    Product Code
    LWS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 24, 2003
    Posted
    October 31, 2003
    Terminated
    February 17, 2005
    Address
    6024 Jean Road, Lake Oswego, OR, 97035-5369

    Description

    Belos VR Implantable Cardioverter Defibrillator (ICD) with version A-K00.1.U/1 programmer software.

    Reason

    Potential for early depletion of Implantable Cardioverter Defibrillator battery.

    Action

    Firm issued a letter dated September 24, 2003 recommending physicians schedule an immediate follow-up to reprogram the affected devices.

    Distribution

    The firm distributes to physicians located throughout the US.

    Quantity

    794 devices