BEUDAMED
    FDA Enforcement Class II Terminated

    PSW 1203.U/1, PSW 1301.U, PSW 1307.U, PSW 1403.U, and PSW 1501.U Pacemaker Programmer software. Software approved for use with BIOTRONIK device programmers (trade names: Renamic and ICS 3000). Allows physicians to program devices to pace exclusively in the left ventricle.

    Recall: Z-2376-2015 · Reported August 19, 2015

    Enforcement

    Recall Number
    Z-2376-2015
    Event ID
    71658
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    BIOTRONIK, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 19, 2015
    Initiation Date
    June 30, 2015
    Classification Date
    August 13, 2015
    Termination Date
    December 24, 2015
    Address
    6024 Jean Rd, N/A, Lake Oswego, OR, 97035-5571, United States

    Description

    PSW 1203.U/1, PSW 1301.U, PSW 1307.U, PSW 1403.U, and PSW 1501.U Pacemaker Programmer software. Software approved for use with BIOTRONIK device programmers (trade names: Renamic and ICS 3000). Allows physicians to program devices to pace exclusively in the left ventricle.

    Reason

    Ventricular packing: LV software programming versions for BIOTRONIK CRT-P and CRT-D devices are recalled because they are not approved for use in the US.

    Code Info

    Affected Product Part Numbers: 394229, 400335, 403222, 406797, 408849

    Distribution

    Nationwide Distribution.

    Quantity

    768 units (software)