BEUDAMED
    FDA Enforcement Class II Terminated

    Philips M3015A Microstream CO2 Extension Model No. 862393 -used with an lntelliVue X3 Patient Monitor (Model No. 867030) or a lntelliVue MMX Multi-Measurement Module (Model No. 867036)

    Recall: Z-2531-2020 · Reported July 15, 2020

    Enforcement

    Recall Number
    Z-2531-2020
    Event ID
    85799
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips North America, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 15, 2020
    Initiation Date
    June 8, 2020
    Classification Date
    July 7, 2020
    Termination Date
    January 9, 2023
    Address
    3000 Minuteman Rd, Andover, MA, 01810-1032, United States

    Description

    Philips M3015A Microstream CO2 Extension Model No. 862393 -used with an lntelliVue X3 Patient Monitor (Model No. 867030) or a lntelliVue MMX Multi-Measurement Module (Model No. 867036)

    Reason

    Affected M3015A extensions are incompatible with the lntelliVue X3 Patient Monitor (Model No. 867030) and lntelliVue MMX multi-measurement server (Model No. 867036).If they are connected to a host monitor, communication with the X3 or MMX could be disrupted, resulting in a loss of monitoring on the host monitor.

    Code Info

    Units with this hardware version can be identified by the following serial number prefix: SN prefix: DE435xxxxx (first five digits)

    Distribution

    Nationwide Foreign: Angola Angola Argentina Australia Austria Bahrain Belarus Belgium Bolivia Brazil Bulgaria Canada Chile China Colombia Costa Rica Croatia Cyprus Czech Republic Denmark Egypt Estonia Finland France French Guiana Germany Ghana Gibraltar Greece Greenland Guadeloupe Guatemala Hong Kong Hungary Iceland India Indonesia Iran Ireland Israel Italy Japan Jordan Kazakhstan Kenya Korea, Republic of Kuwait Latvia Lebanon Lithuania Luxembourg Malaysia Martinique Mexico Morocco Mozambique Namibia Netherlands New Caledonia New Zealand Nicaragua Norway Oman Palestine, State of Paraguay Peru Philippines Poland Portugal Qatar R¿union Russian Federation Saint Pierre and Miquelon Saudi Arabia Singapore Slovakia Slovenia South Africa Spain Sri Lanka Sweden Switzerland Syrian Arab Republic Taiwan Tanzania Thailand Turkey Ukraine United Arab Emirates United Kingdom

    Quantity

    46,597 Units WW