BEUDAMED
    FDA Recall Terminated

    IntelliVue MX700 patient monitor, model no. 865241

    Recall: Z-2697-2020 · Initiated June 30, 2020

    Recall

    Recall Number
    Z-2697-2020
    Event Number
    85908
    Firm
    Philips North America, LLC
    FEI Number
    1218950
    Product Code
    MHX
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    June 30, 2020
    Terminated
    January 25, 2024
    Address
    3000 Minuteman Rd, Andover, MA, 01810-1032

    Description

    IntelliVue MX700 patient monitor, model no. 865241

    Reason

    Some Intellivue MX700/MX800 Patient Monitors were delivered with defective power supplies. The defective power supplies might energize the metal parts of monitor if the grounding instructions were not followed, and may also cause the monitor to stop operating or prevent it from being switched on.

    Action

    On June 30, 2020, the firm sent Urgent Medical Device Correction letters to affected customers. Customers were instructed to always ensure that the monitor is grounded during operation with mains power. Affected products should be removed from use until the power supply of the monitor has been replaced. Philips Customer Service will contact customers when a replacement power supply is ready for installation. Philips expects all replacements to be complete within six months. If you need any further information or support concerning this issue, please contact your local Philips representative or Philips Customer Support at 1-800- 722-9377.

    Distribution

    Domestic distribution to CA, HI, MA, NY, and UT. International distribution to Costa Rica, Ireland, Lebanon, and Poland.

    Quantity

    28