BEUDAMED
    FDA Enforcement Class II Terminated

    ORCHESTRA/ORCHESTRA PLUS Programmer

    Recall: Z-0805-2014 · Reported January 29, 2014

    Enforcement

    Recall Number
    Z-0805-2014
    Event ID
    67013
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Sorin Group Italia S.r.l.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 29, 2014
    Initiation Date
    November 20, 2013
    Classification Date
    January 22, 2014
    Termination Date
    September 8, 2014
    Address
    Via Crescentino, Saluggia, VC, N/A, Italy

    Description

    ORCHESTRA/ORCHESTRA PLUS Programmer

    Reason

    Sorin has voluntarily issued a notification to physicians related to the overestimation of the residual longevity displayed by its programmer (ORCHESTRA or ORCHESTRA PLUS) during a follow-up exam of patients implanted with a REPLY or ESPRIT pacemaker.

    Code Info

    ORCHESTRA/ORCHESTRA PLUS Programmer implanted with the following pacemaker models. - REPLY Models D, DR, VDR, SR - ESPRIT Models D, DR, S, SR - FACIL Model DR1

    Distribution

    Nationwide.

    Quantity

    1,718