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Recall Observatory FDA recall evidence

Device product

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

Z-0133-2026

September 11, 2025

Class II

Product summary

Firm
Ferno-Washington Inc
Event
Event 97606
Status
Ongoing
Classification
Class II
Quantity
138 units
Official record key
device-enforcement:Z-0133-2026

Official wording

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

Code information: 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 pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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