BEUDAMED
    FDA Recall Terminated

    Velara Generator with an old Firmware version used with Philips Allura Xper Systems (Allura 15 & 12 (monoplane), Allura FD10C, Allura FD10F, Allura FD 10 F/C, Allura FD20, Allura XPER FD10/10, Allura XPER FD20 Biplane)

    Recall: Z-1061-2017 · Initiated December 9, 2016

    Recall

    Recall Number
    Z-1061-2017
    Event Number
    76080
    Firm
    Philips Electronics North America Corporation
    FEI Number
    1218950
    Product Code
    IZI
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    December 9, 2016
    Terminated
    July 30, 2020
    Address
    3000 Minuteman Rd, Andover, MA, 01810-1032

    Description

    Velara Generator with an old Firmware version used with Philips Allura Xper Systems (Allura 15 & 12 (monoplane), Allura FD10C, Allura FD10F, Allura FD 10 F/C, Allura FD20, Allura XPER FD10/10, Allura XPER FD20 Biplane)

    Reason

    System may lock up.

    Action

    Consignees were notified of the recall by letter, sent via certified mail on 12/9/16. Philips will upgrade the firmware of the Velara Generator, allowing the Velara Generator to recover in case of intermittent shortcuts. This service will be provided free of charge for all affected systems and will start effective January 2017. A Philips service representative will contact customers with affected devices to arrange for the service.

    Distribution

    US: AL, CA, DC, IL,GA, KS, MD, MO, NC, NY, OH, PA, RI, SC, TX, WA OUS: Brazil, Bulgaria, Costa Rica, France, Germany, Israel, Italy, Japan, Korea, Republic of, Mexico, Russian Federation, Singapore, Spain, Sweden, Switzerland Switzerland, Turkey, United Kingdom

    Quantity

    59 devices (this number represents all products listed in recall)