BEUDAMED
    FDA Enforcement Class II Terminated

    Merlin PCS programmer (Model # 3650), Software (Model # 3330)

    Recall: Z-2329-2018 · Reported July 4, 2018

    Enforcement

    Recall Number
    Z-2329-2018
    Event ID
    80212
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    St Jude Medical Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 4, 2018
    Initiation Date
    April 16, 2018
    Classification Date
    June 28, 2018
    Termination Date
    March 8, 2024
    Address
    15900 Valley View Ct, Sylmar, CA, 91342-3577, United States

    Description

    Merlin PCS programmer (Model # 3650), Software (Model # 3330)

    Reason

    The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) intended to strengthen security by providing an additional layer of protection against unauthorized device access. For older generation devices not capable of accepting the firmware, the firm is advising customers of the option to permanently disable the RF communication capability in these devices.

    Code Info

    Software Versions: 24.1.1 rev1 (US), 23.1.2 rev 1 (OUS), 23.1.3 (Japan), and 23.1.4 rev 1 (Canada)

    Distribution

    U.S. Nationwide distribution

    Quantity

    71651