BEUDAMED
    FDA Recall Open, Classified

    IntelliVue G7m Anesthesia Gas Module, Model no. 866173, Firmware Version 04.12.00, System Codes 453564477391, 453564477401, 866173

    Recall: Z-2689-2020 · Initiated June 25, 2020

    Recall

    Recall Number
    Z-2689-2020
    Event Number
    85795
    Firm
    Philips North America, LLC
    FEI Number
    1218950
    Product Code
    MHX
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    June 25, 2020
    Address
    3000 Minuteman Rd, Andover, MA, 01810-1032

    Description

    IntelliVue G7m Anesthesia Gas Module, Model no. 866173, Firmware Version 04.12.00, System Codes 453564477391, 453564477401, 866173

    Reason

    The device may experience an interruption of gas measurement due to a firmware issue, ceasing measurement and display of gas levels and generating one or more technical or INOP alarms.

    Action

    On 6/25/2020, the firm distributed Customer Information Medical Device Correction letters to affected customers. Customers were informed that the current firmware on the 866173 G7m Gas Module needed to be updated in order to correct an issue which was causing the device to erroneously detect a premature failure of the pump. When the error occurs, the device will cease measurement and display of gas levels, and generate one or more technical or INOP alarms. Customers were instructed to ensure their staff is informed of the actions to be taken for INOP alarms, as can be found in the Instructions for Use. Local Philips Service representatives will contact customers and will update the firmware on affected devices. If you have further questions or concerns about the issue, please contact your local Philips representative or Philips Customer Support at 1-800-722-9377.

    Distribution

    Worldwide distribution - US Nationwide distribution.

    Quantity

    3075