BEUDAMED
    FDA Enforcement Class II Terminated

    Merlin PCS 3650 Programmer with Model 3330 Software Version 23.1.1 The Merlin Patient Care System (PCS) Model 3650 Programmer is a portable, dedicated programming system designed to interrogate program display data and test St. Jude Medical implantable devices.

    Recall: Z-0032-2018 · Reported October 25, 2017

    Enforcement

    Recall Number
    Z-0032-2018
    Event ID
    78093
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    St Jude Medical Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 25, 2017
    Initiation Date
    August 28, 2017
    Classification Date
    October 19, 2017
    Termination Date
    July 8, 2020
    Address
    15900 Valley View Ct, Sylmar, CA, 91342-3577, United States

    Description

    Merlin PCS 3650 Programmer with Model 3330 Software Version 23.1.1 The Merlin Patient Care System (PCS) Model 3650 Programmer is a portable, dedicated programming system designed to interrogate program display data and test St. Jude Medical implantable devices.

    Reason

    New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.

    Code Info

    Software version 23.1.1

    Distribution

    Worldwide Distribution

    Quantity

    10,453 units