BEUDAMED
    FDA Recall 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 · Initiated August 28, 2017

    Recall

    Recall Number
    Z-0032-2018
    Event Number
    78093
    Firm
    St Jude Medical Inc.
    FEI Number
    2017865
    Product Code
    NIK
    Status
    Terminated
    Root Cause
    Unknown/Undetermined by firm
    Initiated
    August 28, 2017
    Terminated
    July 8, 2020
    Address
    15900 Valley View Ct, Sylmar, CA, 91342-3577

    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.

    Action

    Abbott sent an Important Cybersecurity Advisory dated August 28, 2017, to all affected customers to notify customers of the availability of the programmer software update and associated pacemaker firmware update. The notification material is in the form of a Physician Letter and Hospital Letter and will be delivered to physicians and hospitals with inventory in the US by overnight service. Customers with questions were instructed to contact their Abbott representative or the customers technical support hotline at 1-800-722-3774.

    Distribution

    Worldwide Distribution

    Quantity

    10,453 units