BEUDAMED
    FDA Recall Terminated

    Draeger Medical Systems Infinity Acute Care System (M540) Catalog Numbers: MK31501/MK31701/MK31722

    Recall: Z-2734-2017 · Initiated June 6, 2017

    Recall

    Recall Number
    Z-2734-2017
    Event Number
    77505
    Firm
    Draegar Medical Systems, Inc.
    FEI Number
    3005783425
    Product Code
    MHX
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    June 6, 2017
    Terminated
    June 19, 2018
    Address
    6 Tech Dr, Andover, MA, 01810-2434

    Description

    Draeger Medical Systems Infinity Acute Care System (M540) Catalog Numbers: MK31501/MK31701/MK31722

    Reason

    Cockpits with revision index 06 or higher that contain 4GB RAM modules may not annunciate audio or visual alarms on the Cockpit and Central Station.

    Action

    Draeger issued on June 6, 2017 Urgent Medical Recall letter with Addendum US serial numbers via Certified Mail addressed to Risk Manager and Director Clinical Engineering The letter instructs the consignees, if the serial number of the cockpit is on the serial number list, to remove the Cockpit from use until it can be determined whether the 4GB RAM Module is among those affected. The IACS can be used without the Cockpit and the M540 will function as the primary monitoring device once the Cockpit is disconnected. A DrgerService Representative will schedule a time to inspect the Cockpit and, if necessary, replace the 4GB RAM Module. The inspection and 4GB RAM replacement (if necessary) will be performed free of charge. For questions regarding the Operation and/or servicing the Drger Infinity Acute Care System Cockpit contact DrgerService Technical Support at 800-437- 2437 (press 4 at the prompt and then press 4 again). For OUS the responsible local Draeger Sales and Service will mail the letter with Addendum serial number list.

    Distribution

    AZ, NH, SD, TN, TX Foreign: Australia Austria Belgium Canada China Costa Rica France Germany Great Britian Hong Kong India Ireland Italy Japan Malaysia Namibia Netherlands Poland Portugal Russian Fed. South Africa South Korea Spain Sweden Switzerland Thailand Turkey United Kingdom

    Quantity

    37 US and 682 OUS