BEUDAMED
    FDA Recall Terminated

    Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1. Intended for in vivo imaging.

    Recall: Z-1441-2013 · Initiated May 14, 2013

    Recall

    Recall Number
    Z-1441-2013
    Event Number
    65191
    Firm
    Optovue, Inc.
    FEI Number
    3005950902
    Product Code
    HLI
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    May 14, 2013
    Posted
    May 31, 2013
    Terminated
    October 24, 2013
    Address
    2800 Bayview Dr, Fremont, CA, 94538-6518

    Description

    Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1. Intended for in vivo imaging.

    Reason

    Colors from the NDB comparison for Ganglion Cell Complex thickness in the singular OU report in iVue version 3.0 (US) and 3.1(international) are different from those in the individual iWellness ID and OS reports.

    Action

    Optovue sent a Field Correction Notice letter dated May 16, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers.

    Distribution

    Distributed Nationwide and in Canada.

    Quantity

    ~329 users