BEUDAMED
    FDA Enforcement Class II Ongoing

    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 · Reported October 11, 2023

    Enforcement

    Recall Number
    Z-2652-2023
    Event ID
    93069
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    GE MEDICAL SYSTEMS, ISRAEL LTD.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 11, 2023
    Initiation Date
    September 6, 2023
    Classification Date
    September 29, 2023
    Address
    Nativ Haa??or Street no. 1, N/A, HAIFA, N/A, N/A, 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.

    Code Info

    Venue Go Standard Carts, Ref: (H45181VC and H45103VCW) used with Venue Go R2, R3, R4 systems R2, R3, and R4 systems (GTIN 0084068213884, 00840682190503, and 00195278516510) that were manufactured 2022-08 and before

    Distribution

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

    Quantity

    5986 devices