BEUDAMED
    FDA Enforcement Class II Terminated

    Velara Generator with an old Firmware version used with the Philips Integris BH5000

    Recall: Z-1062-2017 · Reported February 1, 2017

    Enforcement

    Recall Number
    Z-1062-2017
    Event ID
    76080
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Electronics North America Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 1, 2017
    Initiation Date
    December 9, 2016
    Classification Date
    January 20, 2017
    Termination Date
    July 30, 2020
    Address
    3000 Minuteman Rd, N/A, Andover, MA, 01810-1032, United States

    Description

    Velara Generator with an old Firmware version used with the Philips Integris BH5000

    Reason

    System may lock up.

    Code Info

    Velara Generator with 12nc number: 989000070011, 989000070122, 989000070123, 989000070124, 989000070125, 989000070126, 989000070321

    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)