BEUDAMED
    FDA Enforcement Class II Terminated

    DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER Is designed for the metered delivery of specific inhalation anesthetic agents for use in continuous flow techniques of inhalation anesthesia.

    Recall: Z-1198-2018 · Reported April 4, 2018

    Enforcement

    Recall Number
    Z-1198-2018
    Event ID
    79493
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    GE Healthcare, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 4, 2018
    Initiation Date
    October 4, 2017
    Classification Date
    March 26, 2018
    Termination Date
    April 10, 2020
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615, United States

    Description

    DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER Is designed for the metered delivery of specific inhalation anesthetic agents for use in continuous flow techniques of inhalation anesthesia.

    Reason

    Non-Conforming devices were shipped from the service center without proper evaluation and therefore may be nonconforming.

    Code Info

    Model # M1107626 Mfg. Lot or Serial #: BEJN05568, BEJM03853, BEJM04539, BEJN05793, BEJP01947, BEJP03924, BEJP04380, BEJP08533, BEJU06631, BEJN06095, BEJP04706, BEJU05053, BEJM04542, BEJM04881, BEJM04901, BEJN07748, BEJN07849, BEJP03230, BEJP03239, BEJP03559, BEJP03984, BEJP05309, BEJP05347, BEJP05825, BEJP05834, BEJP05978, BEJP08567, and BEJP09304.

    Distribution

    US Distribution to states of: AZ, IL NC, NH and PA.

    Quantity

    28