BEUDAMED
    FDA Recall Open, Classified

    DigitalDiagnost C90, Model No. 712034 and 712035

    Recall: Z-2042-2023 · Initiated May 19, 2023

    Recall

    Recall Number
    Z-2042-2023
    Event Number
    92462
    Firm
    Philips North America Llc
    FEI Number
    3016618143
    Product Code
    MQB
    Status
    Open, Classified
    Root Cause
    Software change control
    Initiated
    May 19, 2023
    Posted
    June 30, 2023
    Address
    222 Jacobs St, Cambridge, MA, 02141-2289

    Description

    DigitalDiagnost C90, Model No. 712034 and 712035

    Reason

    There is a software login in issue that may prevent the user from logging in.

    Action

    Consignees in the United States were notified via Urgent Medical Device Correction Letter that was distributed on May 26, 2023. US consignees were initially notified via email. Follow-up notifications via FedEx will follow. Philips Market Organizations are responsible for distributing letters outside of the US in accordance with local requirements. A Philips Field Service Engineer will visit impacted customer sites to perform a software upgrade to prevent the issue from recurring. Philips has requested customers perform the following: a) To prevent the system from becoming inoperable, do not reboot or log out of your system until Philips has implemented the software correction; b) Circulate this notice to all users of the device so that they are aware of the issue; and c) Complete and return the response form to Philips promptly and no later than 30 days from receipt.

    Distribution

    Distribution in US: AZ, GA, IN, IA, MN, NE, NH, OH, TX OUS distribution to Australia, Chile, China, Malta, Namibia, New Zealand, Oman, Panama, Qatar, Suriname, United Kingdom

    Quantity

    58