BEUDAMED
    FDA Recall Terminated

    GE Carestation 620/650/650c, A1 and A2 (non-US distribution) anesthesia systems

    Recall: Z-2954-2018 · Initiated July 24, 2018

    Recall

    Recall Number
    Z-2954-2018
    Event Number
    80693
    Firm
    GE Medical Systems China Co., Ltd. National Hi-Tech No.
    FEI Number
    3003513129
    Product Code
    BSZ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    July 24, 2018
    Terminated
    December 16, 2020
    Address
    19 Changjiang Road, Dev. Zone Wuxi China

    Description

    GE Carestation 620/650/650c, A1 and A2 (non-US distribution) anesthesia systems

    Reason

    On systems equipped with the Auxiliary Common Gas Outlet (ACGO), there is a potential for the auxiliary gas switch to unexpectedly switch from the ACGO position back to the circle position. On systems equipped with the Aux O2 + Air function the switch could unexpectedly switch from the Aux O2 + Air position back to the circle position. These situations could lead to hypoxia.

    Action

    The firm issued a medical device correction notice on 07/24/2018. The notice explained the issue and provided safety instructions should the use observe a switch change. The units will be corrected. Questions or concerns may contact 1-800-437-1171 or the local service representative.

    Distribution

    Worldwide

    Quantity

    310 units