BEUDAMED
    FDA Enforcement Class II Terminated

    Merlin PCS 3650 Software Upgrade Kit, REF 3330 St. Jude Medical The MerlinTM Patient Care System (MerlinTM PCS) Model 3650 is a portable, dedicated programming system designed to interrogate, program, display data, and test St. Jude MedicalTM implantable devices and leads.

    Recall: Z-1700-2020 · Reported April 22, 2020

    Enforcement

    Recall Number
    Z-1700-2020
    Event ID
    85275
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Abbott
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 22, 2020
    Initiation Date
    February 28, 2020
    Classification Date
    April 10, 2020
    Termination Date
    April 18, 2024
    Address
    15900 Valley View Ct, Sylmar, CA, 91342-3577, United States

    Description

    Merlin PCS 3650 Software Upgrade Kit, REF 3330 St. Jude Medical The MerlinTM Patient Care System (MerlinTM PCS) Model 3650 is a portable, dedicated programming system designed to interrogate, program, display data, and test St. Jude MedicalTM implantable devices and leads.

    Reason

    Internal testing of software identified software anomaly scenarios where if non-applicable shock energy value is selected, the device will continue to use the previously programmed energy level and the user will not be alerted that the selected value was not retained.

    Code Info

    Software Version: 24.6.1 Model: 3650, GTIN: 05414734500661 Model: 3330, GTIN: 05414734509725 For affected serial number of programmers see Attachment B.1 Programmers For models of ICDs interrogated by affected programmers see Attachment B.2 Devices.

    Distribution

    U.S. AK, Al, AR, AZ, CA, CO, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, NC, ND, NE, NH, NJ, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, WI, and WV. OUS: None - the firm stated that there are no OUS consignees associated to ICDs that were interrogated from January 22, 2020 to February 6, 2020.

    Quantity

    Software Version 24.6.1 installed into 4733 programmers