BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1199-2018 · Initiated October 4, 2017

    Recall

    Recall Number
    Z-1199-2018
    Event Number
    79493
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    BSZ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    October 4, 2017
    Terminated
    April 10, 2020
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    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.

    Action

    The firm, GE healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated October 4th, 2017 to all their customers. The letter described the product, problem and actions to be taken. The customers were instructed to contact GE Service to obtain an RMA number. GE Healthcare has arranged with Piramal Inc. to replace the affected products at no cost. If you have any questions or concern regarding this notification please contact GE healthcare Service at 1-800-437-1171 or your local representative.

    Distribution

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

    Quantity

    2