{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "216084", "product_res_number": "Z-0133-2026", "event_date_initiated": "2025-09-11", "event_date_posted": "2025-10-10", "recall_status": "Open, Classified", "res_event_number": "97606", "product_code": "FPO", "product_description": "FERNO POWER X2 POWERED AMBULANCE COT, Model/Catalog Number: 0015816; FOR USE IN GROUND TRANSPORTATION AMBULANCES.", "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", "firm_fei_number": "1523574", "recalling_firm": "Ferno-Washington Inc", "address_1": "70 Weil Way", "city": "Wilmington", "state": "OH", "postal_code": "45177-9371", "additional_info_contact": "DOROTHY RAMSEY\n1-937-2832885", "reason_for_recall": "The fastening post hardware could loosen allowing the fastening post to detach from the cot", "root_cause_description": "Device Design", "action": "FERNO issued an URGENT PRODUCT CORRECTION notice to its consignees on 09/11/2025 via USPS certified mail. The notice explained the issue, potential risk to user, and requested the consignee identify the affected unit, inspect it using the following criteria: \nVisual Inspection\n\" Look for gaps between the fastener head and the surface.\n\" Check for missing fasteners.\n\" Look for shiny wear marks, rust streaks, or metal shavings around the fastener these\ncan indicate movement.\n\" Inspect for vibration marks (circular or elongated wear around bolt holes).\nPhysical/Manual Check\n\" Hand-check: Use your fingers or a small wrench to see if the fastener turns easily\nwhen it should not.\n\" Shake or tap test: Lightly tap the fastener or surrounding component with a\nnon-marring tool; rattling or movement suggests looseness.\nFunctional Signs\n\" Listen for unusual rattling or vibration during operation.\n\" Check for misalignment of connected parts (hinges, brackets, covers, panels).\n\" Watch for loosened thread-locking compounds if broken, the fastener may have shifted. \nIF A COT IS FOUND TO HAVE LOOSE OR MISSING HARDWARE, YOU MUST IMMEDIATELY REMOVE IT FROM SERVICE UNTIL THE REPAIR IS COMPLETE. \nUpon receipt of this Notice, please call Ferno Technical Support at 866-987-3776 or email tscoordinator@ferno.com to (1) acknowledge receipt of this notice, (2) advise if any of your Power X2 serial numbers are affected, (3) advise if and how many of your affected serial numbers contain loose and/or missing hardware on the fastening post, and (4) make arrangements for trained service technicians to correct your ambulance cot.\nIn the event you sold or donated the identified product, please forward this notice to your consignee and advise Ferno of the consignee information so we may follow up. \nMalfunctions or quality problems experienced with the use of your POWER X2 Powered Ambulance Cot may be reported to Ferno at 866-987-3776 or tscoordinator@ferno.com", "product_quantity": "138 units", "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.", "openfda": { "k_number": [ "K840122", "K904011", "K072598", "K854304", "K972528", "K113598", "K932260", "K792570", "K884759", "K844578", "K840125", "K840920", "K933366", "K943529", "K942948", "K922808", "K920704", "K881845", "K863083", "K873181", "K761147", "K935297", "K922809", "K945431", "K943262", "K862959", "K943864", "K933071", "K961437", "K955766", "K840124", "K861410", "K946101", "K902503", "K933060", "K914543", "K900872", "K853421", "K874332", "K943969", "K864269", "K801935", "K895740", "K862441", "K943528", "K923730", "K871556", "K843439", "K962181", "K952447" ], "registration_number": [ "", "3007802293", "3030488262", "3037012186", "3007123908", "3008042739", "3014270896", "1721113", "3011910987", "3017421556", "1824206", "1033902", "3027332478", "3014739961", "3007583774", "3008058231", "3005070829", "3006554924", "9613910", "3008386649", "2518443", "8010652", "3003749961", 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