BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-2523-2020 · Initiated June 2, 2020

    Recall

    Recall Number
    Z-2523-2020
    Event Number
    85810
    Firm
    Philips North America, LLC
    FEI Number
    1218950
    Product Code
    JAA
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    June 2, 2020
    Posted
    July 10, 2020
    Terminated
    February 9, 2021
    Address
    3000 Minuteman Rd, Andover, MA, 01810-1032

    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.

    Action

    The firm distributed Urgent Field Safety Notice letters to affected customers on 6/2/2020. Customers were informed that the thermos switches may be incorrectly installed which results in a malfunction. If the transformer overheats due to a failure and the thermos switch is not activated, the device may begin to generate smoke. Customers were advised by the firm that they can use the system according to the IFU (Instruction for Use). The user should pay attention to whether it smells of smoke in the room. If this is the case, immediately shut down the system according to IFU or (if present) use emergency off switch in room, remove patient, stop using the system for further examinations and contact customer service. Philips plans to perform an On-Site check of the SPDU thermo contact at affected systems, which will eliminate these issues. Should you need to communicate with Philips with regard to this program, please reference Field Change Order 70600103. If you need any further information or support concerning this issue, please contact your local Philips representative.

    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