BEUDAMED
    FDA Enforcement Class II Terminated

    EasyDiagnost Eleva DRF, model no. 706050 - Product Usage: X-ray system, diagnostic, general-purpose.

    Recall: Z-2523-2020 · Reported July 15, 2020

    Enforcement

    Recall Number
    Z-2523-2020
    Event ID
    85810
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips North America, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 15, 2020
    Initiation Date
    June 2, 2020
    Classification Date
    July 7, 2020
    Termination Date
    February 9, 2021
    Address
    3000 Minuteman Rd, Andover, MA, 01810-1032, United States

    Description

    EasyDiagnost Eleva DRF, model no. 706050 - Product Usage: X-ray system, diagnostic, general-purpose.

    Reason

    Thermo switches in the main power supply for the system may be incorrectly installed, resulting in a malfunction.

    Code Info

    Serial Numbers SN16000004 SN17000018 SN17000020 SN17000025 SN17000026 SN18000002 SN18000004 SN18000005 SN16000002 SN16000006 SN16000011 SN16000013 SN16000017 SN16000022 SN16000025 SN16000028 SN16000029 SN16000030 SN16000031 SN16000036 SN16000037 SN16000039 SN16000041 SN16000042 SN16000043 SN16000044 SN16000045 SN16000048 SN16000054 SN16000056 SN17000001 SN17000006 SN17000008 SN17000015 SN17000017 SN17000019 SN17000021 SN17000023 SN17000027 SN17000028 SN17000029 SN17000031 SN17000032 SN17000033 SN17000034 SN17000035 SN17000036 SN17000037 SN17000038 SN18000001 SN18000003 SN18000009

    Distribution

    Worldwide distribution - US Nationwide distribution including in the states of AR, AZ, CA, CT, FL, GA, HI, IL, LA, MA, MD, MI, MS, MT, NC, NY, TN, TX and the country of Panama.

    Quantity

    52