BEUDAMED
    FDA Enforcement Class II Ongoing

    FERNO POWER X2 POWERED AMBULANCE COT, Model/Catalog Number: 0015816; FOR USE IN GROUND TRANSPORTATION AMBULANCES.

    Recall: Z-0133-2026 · Reported October 22, 2025

    Enforcement

    Recall Number
    Z-0133-2026
    Event ID
    97606
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Ferno-Washington Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 22, 2025
    Initiation Date
    September 11, 2025
    Classification Date
    October 10, 2025
    Address
    70 Weil Way, Wilmington, OH, 45177-9371, United States

    Description

    FERNO POWER X2 POWERED AMBULANCE COT, Model/Catalog Number: 0015816; FOR USE IN GROUND TRANSPORTATION AMBULANCES.

    Reason

    The fastening post hardware could loosen allowing the fastening post to detach from the cot

    Code Info

    UDI-DI 00190790003210, Serial Numbers: 25G036127,25G036128, 25G036151, 25G036152, 25G036153, 25G036154, 25G036155, 25G036156, 25G036157, 25G036158, 25G036267, 25G036268, 25G036269, 25G036612, 25G036613, 25G036614, 25G036652, 25G036653, 25G036654, 25G036801, 25G036802, 25G036803, 25G036804, 25G036827, 25G036828, 25G036829, 25G036830, 25G036833, 25G036834, 25G036835, 25G036836, 25G036837, 25G036921, 25G036922, 25G036923, 25G036924, 25G036925, 25G036926, 25G036927, 25G036928, 25G036929, 25G036930, 25G036951, 25G036952, 25G036953, 25G036954, 25G036958, 25G036959, 25G036960, 25G036961, 25G036962, 25G036963, 25G036964, 25G037067, 25G037068, 25G037069, 25G037070, 25G037071, 25G037072, 25G037093, 25G037094, 25G037095, 25G037096, 25G037097, 25G037098, 25G037100, 25G037159, 25G037160, 25G037161, 25G037162, 25G037163, 25G037165, 25G037215, 25G037216, 25G037217, 25G037218, 25G037219, 25G037222, 25G037223, 25G037224, 25G037225, 25G037226, 25G037227, 25G037228, 25G037229, 25G037271, 25G037272, 25G037273, 25G037274, 25G037275, 25G037276, 25G037277, 25G037278, 25G037279, 25G037280, 25G037281, 25G037282, 25G037283, 25G037284, 25G037285, 25G037286, 25G037287, 25G037288, 25G037289, 25G037298, 25G037299, 25G037300, 25G037301, 25G037302, 25G037303, 25G037304, 25G037305, 25G037336, 25G037337, 25G037338, 25G037339, 25G037340, 25G037341, 25G037342, 25G037344, 25G037345, 25G037346, 25G037347, 25G037466, 25G037467, 25G037468, 25G037469, 25G037470, 25G037471, 25G037472, 25G037473, 25G037474, 25G037526, 25G037595, 25G037596, 25G037597, 25G037598, 25G037599, 25G037600, 25G037601, 25G037602, 25G037623, 25G037665, 25G037691, 25G037692, 25G037703, 25G037704, 25G037707, 25G037766, 25G037767, 25G037768, 25G037769, 25G037770, 25G037772, 25G037774, 25G037780, 25G037781, 25G037782, 25G037786, 25G038074, 25G038075, 25G038076, 25G038077, 25G038079, 25G038082, 25G038083, 25G038084, 25G038088, 25G038089, 25G038090, 25G038536, 25G038537, 25G038538, 25G038539, 25G038540, 25G038564, 25G038575, 25G038576, 25G038577, 25G038578, 25G038615, 25G038616, 25G038617, 25G038618, 25G038619, 25G038625, 25G038626, 25G038627, 25G038628, 25G038698, 25G038754, 25G038765, 25G038766, 25G038767, 25G038768, 25G038769

    Distribution

    US Nationwide distribution in the states of AL, AR, AZ, CA, CO, FL, IS, IL, KY, LA, MN, MO, NC, ND, NE, NM, NY, OH, OK, PA, TN, TX, UT, VA, WI, WV.

    Quantity

    138 units