BEUDAMED
    FDA Recall Terminated

    The ORCHESTRA PLUS Programmer A portable device, equipped with a microprocessor used to program and interrogate Sorin implantable pacemakers and defibrillators. The programmer also provides measurement, ECG display and report printing functions that are essential for monitoring implant patients.

    Recall: Z-0413-2017 · Initiated September 29, 2016

    Recall

    Recall Number
    Z-0413-2017
    Event Number
    75456
    Firm
    Sorin Group USA, Inc.
    FEI Number
    1718850
    Product Code
    KRG
    Status
    Terminated
    Root Cause
    Software Design Change
    Initiated
    September 29, 2016
    Terminated
    May 15, 2020
    Address
    14401 W 65th Way, Arvada, CO, 80004-3503

    Description

    The ORCHESTRA PLUS Programmer A portable device, equipped with a microprocessor used to program and interrogate Sorin implantable pacemakers and defibrillators. The programmer also provides measurement, ECG display and report printing functions that are essential for monitoring implant patients.

    Reason

    Sorin Group USA, Inc. announces a voluntary field action for the ORCHESTRA Programmer and ORCHESTRA PLUS Programmer because the residual longevity estimate may be less accurate.

    Action

    The firm, LivaNova, sent an "Urgent Field Safety Notice" dated 9/29/2016 to its customers. The notice described the product, problem, actions to be taken. The notice states that a Sorin representative will contact customers to upgrade the software in the facility's programmer. If customers have any questions, they are urged to call their LivaNova representative or contact LivaNova Technical Services at 877.663.7674.

    Distribution

    Programmers were distributed nationwide, to VA/govt/military, Canadian, and other foreign consignees.

    Quantity

    586 programmers