BEUDAMED
    FDA Recall Open, Classified

    Venue Go Standard Carts Ref: (H45181VC and H45103VCW), used with Venue Go R2, R3, R4 systems R2, R3, and R4 systems; pulsed doppler imaging system

    Recall: Z-2652-2023 · Initiated September 6, 2023

    Recall

    Recall Number
    Z-2652-2023
    Event Number
    93069
    Firm
    GE MEDICAL SYSTEMS, ISRAEL LTD. Nativ Haa??or Street no.
    FEI Number
    3002973981
    Product Code
    IYN
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    September 6, 2023
    Posted
    September 29, 2023
    Address
    1 HAIFA Israel

    Description

    Venue Go Standard Carts Ref: (H45181VC and H45103VCW), used with Venue Go R2, R3, R4 systems R2, R3, and R4 systems; pulsed doppler imaging system

    Reason

    Some Venue Go Standard Carts can develop an internal failure of the vertical/horizontal tilt adjustment mechanism which can result in the Venue Go system detaching from the cart and falling.

    Action

    The recalling firm issued letters dated 9/6/2023 via FedEx in the U.S. which explained the safety issue and actions to be taken by the customer/user. The actions included: On a weekly basis, check the vertical/horizontal tilt adjustment mechanism on the Venue Go Standard Cart to ensure it is secure: (1) Lock the wheels; (2) Raise the up/down adjustment column to its highest position; (3) Observe the tilt mechanism during side-to-side rocking as is shown in the photos in the letter. If the vertical/horizontal tilt adjustment mechanism is loose, the consignee is to (1) remove the Venue Go system from the Cart cradle and place on a tabletop using the adjustable rear support stand; and (2) Do not use the Venue Go Standard Cart until the corrective action is performed by GE HealthCare. All potential users i the facility are to be made aware of the safety notification and recommended actions. An acknowledgement form was enclosed for completion and return to the firm. In addition, the letter provided specific affected product details along with photographs on how to identify the manufacture date on the Venue Go Standard Cart since the affected devices that were impacted were manufactured 2022-08 and before. GE HealthCare will correct all affected products and a representative will contact the consignee to arrange for correction.

    Distribution

    Worldwide distribution - US Nationwide distribution including government and military distribution as well as PR.

    Quantity

    5986 devices