BEUDAMED
    FDA Enforcement Class II Terminated

    The Vesa 75/100 adaptation with rotation is an accessory to a surgical camera intended to be used to record operative procedures.

    Recall: Z-1188-2016 · Reported March 23, 2016

    Enforcement

    Recall Number
    Z-1188-2016
    Event ID
    73348
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Richard Wolf Medical Instruments Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 23, 2016
    Initiation Date
    February 29, 2016
    Classification Date
    March 17, 2016
    Termination Date
    July 3, 2019
    Address
    353 Corporate Woods Pkwy, Vernon Hills, IL, 60061-3110, United States

    Description

    The Vesa 75/100 adaptation with rotation is an accessory to a surgical camera intended to be used to record operative procedures.

    Reason

    Supplier of the "VESA 75 / 100 adaptation with rotation", which is part of their monitor mounts and support arms may be missing riveting.

    Code Info

    FLEXION-PORT 400 (68cm) with Product number 32116068 and the following affected serial numbers: 001X001107, 001X001108, 001X001109, 001X001110, 001X001111, 001X001142, 001X001143, 001X001144, 001X001145, 001X001146, 001X001147, 001X001148, 001X001149, 001X001150, 001X001151, 001X001168, 001X001169, 001X001170, 001X001171, 001X001172, 001X001216, 001X001217, 001X001218, 001X001219, 001X001220, 001X001221, 001X001222, 001X001223, 001X001224, 001X001225, 001X001226, 001X001227, 001X001228, 001X001230, 001X001256, 001X001257, 001X001258, 001X001259, 001X001260, 001X001261, 001X001262, 001X001263, 001X001264, 001X001265, 001X001376, 001X001377, 001X001378, 001X001379, 001X001380, 001X001381, 001X001382, 001X001383, 001X001384, 001X001385 and 001X001229. FLEXION-PORT 300+350 (93cm) with Product number 32116093 and the following affected serial numbers: 001X001173, 001X001174, 001X001175, 001X001176, 001X001177, 001X001235, 001X001237, 001X001239, 001X001299, 001X001309, 001X001310, 001X001313, 001X001314, 001X001315, 001X001366, 001X001367, 001X001368, 001X001369, 001X001370, 001X001371, 001X001372, 001X001373, 001X001374, 001X001375, 001X001402, 001X001403, 001X001406, 001X001231, 001X001232, 001X001233, 001X001234, 001X001236, 001X001238, 001X001240, 001X001296, 001X001297, 001X001298, 001X001300, 001X001301, 001X001302, 001X001303, 001X001304, 001X001305, 001X001306, 001X001307, 001X001308, 001X001311, 001X001312, 001X001404, 001X001405, 001X001439, 001X001440, 001X001441, 001X001442, 001X001443, 001X001444, 001X001445, 001X001446, 001X001447 and 001X001448. FLEXION-PORT 400+350 (103cm) with Product number 32116103 and the following affected serial numbers: 001X001241, 001X001242, 001X001243, 001X001244, 001X001245, 001X001246, 001X001247, 001X001248, 001X001249, 001X001250, 001X001321, 001X001323, 001X001324, 001X001325, 001X001336, 001X001337, 001X001338, 001X001339, 001X001340, 001X001341, 001X001342, 001X001343, 001X001344, 001X001345, 001X001316, 001X001317, 001X001318, 001X001319, 001X001320 and 001X001322.

    Distribution

    Nationwide Distribution including Virginia, Pennsylvania, Florida, California, Texas, North Carolina and Illinois.

    Quantity

    108 units