FDA Medical Device Recalls (openFDA)
Ferno-Washington Inc: FERNO POWER X2 POWERED AMBULANCE COT, Model/Catalog Number: 0015816; FOR USE IN GROUND TRANSPORTATION AMBULANCES.
- Recall number
- Z-0133-2026
- Recalling firm
- Ferno-Washington Inc
- Product
- FERNO POWER X2 POWERED AMBULANCE COT, Model/Catalog Number: 0015816; FOR USE IN GROUND TRANSPORTATION AMBULANCES.
- Status
- Open, Classified
- Initiated
- 2025-09-11
- Posted
- 2025-10-10
- Terminated
- not on file
- Reason
- The fastening post hardware could loosen allowing the fastening post to detach from the cot
- Root cause
- 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: Visual Inspection " Look for gaps between the fastener head and the surface. " Check for missing fasteners. " Look for shiny wear marks, rust streaks, or metal shavings around the fastener these can indicate movement. " Inspect for vibration marks (circular or elongated wear around bolt holes). Physical/Manual Check " Hand-check: Use your fingers or a small wrench to see if the fastener turns easily when it should not. " Shake or tap test: Lightly tap the fastener or surrounding component with a non-marring tool; rattling or movement suggests looseness. Functional Signs " Listen for unusual rattling or vibration during operation. " Check for misalignment of connected parts (hinges, brackets, covers, panels). " Watch for loosened thread-locking compounds if broken, the fastener may have shifted. IF A COT IS FOUND TO HAVE LOOSE OR MISSING HARDWARE, YOU MUST IMMEDIATELY REMOVE IT FROM SERVICE UNTIL THE REPAIR IS COMPLETE. Upon 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. In 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. Malfunctions 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
- Quantity
- 138 units
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FPO
- Firm FEI
- 1523574
- Firm city
- Wilmington
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28