BEUDAMED
    FDA Enforcement Class II Terminated

    DATEX-OHMEDA AISYS CS2 ALADIN2 CASSETTE Cassettes are intended to be used to deliver anesthetic agent.

    Recall: Z-1199-2018 · Reported April 4, 2018

    Enforcement

    Recall Number
    Z-1199-2018
    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 AISYS CS2 ALADIN2 CASSETTE Cassettes are intended to be used to deliver anesthetic agent.

    Reason

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

    Code Info

    Model 1100-9034-000 Mfg. Lot or Serial # BGBQ00675 and BGBQ01187

    Distribution

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

    Quantity

    2