BEUDAMED
    FDA Enforcement Class II Ongoing

    GM60A. Digital Diagnostic Mobile X-Ray System.

    Recall: Z-2715-2024 · Reported August 28, 2024

    Enforcement

    Recall Number
    Z-2715-2024
    Event ID
    95100
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    NeuroLogica Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 28, 2024
    Initiation Date
    July 8, 2024
    Classification Date
    August 22, 2024
    Address
    14 Electronics Ave, Danvers, MA, 01923-1011, United States

    Description

    GM60A. Digital Diagnostic Mobile X-Ray System.

    Reason

    Potential for the anti-fall system of the device arm to fail.

    Code Info

    UDI: 08806088511153/ 08806088088266; Serial No. G69812, G69821, G69824, G69986, G69987, G71422, G71425, G71431, G71434, G71795, G71798, G71802, G72052, G72053, G72264, G72279, G72296, G72301, G72310, G72313, G72319, G72320, G72481, G72484, G72595, G72601, G72853, G72875, G73179, G73184, G73542; Samsung Serial No. 50WFM9BG900003M, 50WFM9BG900004J, 50WFM9BG900005H, 50WFM9BGA00001T, 50WFM9BGA00002B, 50WFM9BH300001E, 50WFM9BH300002W, 50WFM9BH300003Z, 50WFM9BH300004N, 50WFM9BH400001X, 50WFM9BH400002W, 50WFM9BH400003A, 50WFM9BH500001H, 50WFM9BH500002Y, 50WFM9BH600001P, 50WFM9BH600002L, 50WFM9BH600003F, 50WFM9BH600004Y, 50WFM9BH600005W, 50WFM9BH600006N, 50WFM9BH600007K, 50WFM9BH600008J, 50WFM9BH700002B, 50WFM9BH700001P, 50WFM9BH700003M, 50WFM9BH700004E, 50WFM9BH800002E, 50WFM9BH800003D, 50WFM9BH900001X, 50WFM9BH900002D, 50WFM9BHB00001T.

    Distribution

    US Nationwide distribution in the states of AR, CT, GA, IN, KS, MA, MD, MO, MS, NC, ND, NJ, NV, OH, PA, VA, WV & DC.

    Quantity

    31 units