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U.S. Department of Health and Human Services

Class 2 Device Recall Power F2 Powered Fastening System

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 Class 2 Device Recall Power F2 Powered Fastening Systemsee related information
Date Initiated by FirmApril 28, 2026
Date PostedOctober 09, 2026
Recall Status1 Open3, Classified
Recall NumberZ-0145-2027
Recall Event ID 99861
Product Classification Stretcher, wheeled - Product Code FPO
ProductPower F2 Powered Fastening System, Power F2, Item No. 0567093 used with Power X2 Stretchers, Power X2, Item No. 0015816 and PowerX2 Premium, Item No. 0015821
Code Information Power F2 UDI-DI 00190790006570 Firmware versions: PF2 Carriage V0.51/V1.42, PF2 Rail V0.41, PF2 Connect V108 Serial Numbers 25C227687 25C228205 25C228204 25C227690 25C227691 25C227692 25C227688 25C227689 25C227695 25C227700 25C227698 25C227699 25C227702 25C227703 25C227704 25C227696 25C227701 25C227710 25C227708 25C227711 26C231799 26C231800 26C231801 25C227709 25C227707 26C231797 26C232002 26C232004 26C232007 26C232005 26C232008 26C232009 26C231798 26C232010 26C232006 26C232011 26C232374 26C232377 26C232375 26C232379 26C232378 26C232382 26C232717 26C232715 26C232380 26C232384 26C232710 26C232713 26C233032 26C232381 26C232712 26C232718 26C232716 26C233035 26C232714 26C233033 26C233038 26C233041 26C233090 26C233040 26C233039 26C233037 26C233092 26C233036 26C233091 26C233094 26C233111 26C232711 26C233098 26C233097 26C233095 26C233096 26C233115 26C233114 26C233099 26C233113 26C233112 26C233117 26C233443 26C233119 26C233120 26C233118 26C233444 26C233451 26C233450 26C233449 26C233452 26C233692 26C233694 26C233693 26C233697 26C233699 26C233696 26C233701 26C233700 26C234074 26C234078 26C234072 26C234073 26C234076 26C233698 26C234077 26C234079 26C234080 26C234081 26C234082 26C234083 26C234071 26C234084 26C234085 26C234087 26C234086 26C234088 26C234356 26C234346 26C234353 26C234566 26C234352 26C234357 26C234361 26C234359 26C234355 26C234350 26C234362 26C234630 26C234363 26C234364 26C234649 26C234639 26C234632 26C234634 26C234631 26C234635 26C234648 26C234641 26C234640 26C234644 26C234646 26C234642 26C234647 26C234799 26C234797 26C234800 26C234805 26C234812 26C234567 26C234807 26C234801 26C234806 26C234810 26C234804 26C234808 26C234811 26C234814 26C234636 26C234809 26C235037 26C234813 26C234815 26C234816 26C235036 26C235045 26C235047 26C235048 26C235044 26C235046 26C235041 26C235049 26C235050 26C235052 26C235053 26C235054 26C235139 26C235135 26C235137 26C235055 26C235136 26C235138 26C235143 26C235134 26C235141 26C235142 26C235140 26C235144 26C235147 26C235151 26C235149 26C235150 26C235146 26C235148 26C235145 26C235152 26C235431 26C235429 26C235433 26C235432 26C235434 26C235438 26C235437 26C235436 26C235443 26C235446 26C235444 26C235445 26C235686 26C235447 26C235687 26C235700 26C235693 26C235696 26C235688 26C235692 26C235695 26C235697 26C235698 26C235699 26C235702 26C235694 26C235705 26C235701 26C236027 26C235703 26C236029 26C236030 26C236032 26C236035 26C235704 26C236028 26C236038 26C236039 26C236037 26C236042 26C236036 26C236034 26C236033 26C236040 26C236041 26C236026 26C236107 26C236109 26C236110 26C236043 26C236044 26C236045 26C236105 26C236108 26C236106 26C236116 26C236119 26C236113 26C236112 26C236244 26C236121 26C236245 26C236122 26C236123 26C236246 26C236250 26C236255 26C236118 26C236247 26C236729 26C236124 26C236254 26C236257 26C236258 26C236249 26C236260 26C236262 26C236734 26C236256 26C236728 26C236735 26C236731 26C236736 26C236732 26C236733 26C236737 26C236741 26C236746 Power X2 UDI-DI 00190790003210 (Power X2) and 00190790006600 (PowerX2 Premium) Firmware versions PX2 V1.11/V1.18 Serial Numbers 25G036128 25G036612 25G036614 25G036801 25G036802 25G036803 25G036804 25G036827 25G036830 25G036833 25G036834 25G036835 25G036837 25G036836 25G036953 25G036954 25G036958 25G036959 25G036960 25G036961 25G036962 25G036963 25G036964 25G037067 25G037068 25G037071 25G037094 25G037072 25G037095 25G037098 25G037100 25G037161 25G037163 25G037217 25G037225 25G037226 25G037227 25G037228 25G037229 25G037285 25G037289 25G037288 25G037298 25G037299 25G037305 25G037338 25G037342 25G037337 25G037466 25G037467 25G037468 25G037470 25G037471 25G037472 25G037473 25G037474 25G037526 25G037596 25G037595 25G037623 25G037665 25G037691 25G037692 25G037705 25G037707 25G037703 25G037704 25G037706 25G037713 25G037770 25G037772 25G037774 25G037780 25G037781 25G037782 25G038074 25G038075 25G038076 25G038080 25G038081 25G038082 25G038079 25G038083 25G038084 25G038536 25G038088 25G038539 25G038540 25G038615 25G038616 25G038617 25G038618 25G038625 25G038627 25G038578 25G038626 25G038619 25G038765 25G038767 25G038766 25G038768 25G038769 25G038948 25G038991 25G039003 25G039001 25G039002 25G039004 25G039005 25G039068 25G039069 25G039070 25G039065 25G039066 25G039067 25G039072 25G039071 25G039073 25G039189 25G039188 25G039191 25G039192 25G039193 25G039210 25G039248 25G039249 25G039190 25G039350 25G039653 25G039720 25G039728 25G039724 25G039725 25G039726 25G039727 25G039728 25G039737 25G039730 25G039732 25G039738 25G039729 25G039754 25G039736 25G040014 25G040015 25G040016 25C227713 25C227714 25G039773 25G040077 25G040078 25G040079 25G039774 25G039776 25G040073 25G040074 25G039775 25G040075 25G040076 25G039878 25G039879 26G046003 26G046004 26G046005 26G046006 25G039777 25G039872 25G040062 26G046007 26G046008 26G046009 26G046010 26G046011 26G046012 26G046013 26G046014 26G046015 26G046049 26G046051 26G046052 25G039881 26G046048 26G046111 26G046050 25G039779 25G039882 25G040061 26G046045 26G046046 26G046110 26G046112 26G046113 25G039880 26G046047 26G046105 25G040070 26G046016 26G046103 26G046106 26G046109 25G040067 25G040069 25G040071 25G040072 26G046236 26G046237 26G046239 25G040068 26G046238 26G046240 26G046265 26G046266 26G046267 26G046268 26G046269 26G046313 26G046318 26G046319 26G046320 26G046321 26G046310 26G046311 26G046312 26G046314 26G046315 26G046316 26G046317 26G046336 26G046322 26G046334 26G046335 26G046324 26G046401 26G046389 26G046388 26G046390 26G046393 26G046396 26G046397 26G046398 26G046399 26G046400 26G046455 26G046458 26G046459 26G046391 26G046394 26G046454 26G046456 26G046457 26G046460 26G046461 26G046387 26G046392 26G046395 26G046629 26G046630 26G046631 26G046632 26G046633 26G046634 26G046635 26G046636 26G046637 26G046638 26G046721 26G046722 26G046583 26G046855 26G046580 26G046581 26G046646 26G046774 26G046802 26G046805 26G046806 26G046803 26C234762 26C234763 26C234764 26C234765 26C234766 26C234767 26G046808 26C234770 26C234771 26G046582 26G046647 26G046723 26G046801 26G046804 26G046807 26G046818 26C234768 26G046775 26G046819 26G046820 26G046821 26G046822 26G046856 26G046857 26G046859 26G046884 26G046882 26G046883 26G046885 26G046858 26G046887 26G046888 26G046907 26G046908 26G046909 26G046910 26G046911 26G046927 26G046928 26G046923 26G046924 26G046925 26G046987 26G046988 26G046989 26G046886 26G046926 26G046929 26G046984 26G046985 26G046982 26G046983 26G046986 26G047001 26G046996 26G046997 26G046998 26G046999 26G047002 26G047003 26G047004 26G047066 26C236801 26G047008 26G047009 26G047012 26G047013 26C236726 26C236727 26G047000 26G047010 26G047014 26G047011 26G047059 26G047060 26G047061 26G047062 26G047099 26C236723 26C236725 26G047063 26G047064 26G047097 26C236803 26C236804 26C236722 26C236802 26C236805 26C236806 26C236807 26C236840 26C236841 26C236724 26C236842 26C236843 26C236844 26C236854 26C236932 26C236935 26C236857
FEI Number 1523574
Recalling Firm/
Manufacturer		 Ferno-Washington Inc
70 Weil Way
Wilmington OH 45177-9371
For Additional Information ContactDorothy Ramsey
1-937-2832885
Manufacturer Reason
for Recall		Firmware issue may result in intermittent loss or degradation of powered functionality when paired with compatible stretcher. The issue may lead to the system not operating in powered mode, or exhibiting reduced powered performance. Issue may result in interruption or delay in patient transport.
FDA Determined
Cause 2		Software design
ActionFirm began notifying customers on April 28, 2026. Customers were informed that their Power F2 system would be receiving a firmware update. PX2 firmware was also updated to ensure consistent communication with PF2 Connect. Instruction to Customers: Until your Power F2 system has been updated: - continue to use the device in accordance with the instructions for use - if powered functionality is not available, transition to manual operation as needed -ensure personnel are familiar with manual operations procedures
Quantity in Commerce319
DistributionWorldwide - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, FL, ID, IL, KY, LA, ME, MN, MO, MT, NC, NE, NJ, NM, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI, WV and the countries of Netherlands and Poland.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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