{ "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": "2026-10-12", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "222747", "product_res_number": "Z-0145-2027", "event_date_initiated": "2026-04-28", "event_date_posted": "2026-10-09", "recall_status": "Open, Classified", "res_event_number": "99861", "product_code": "FPO", "product_description": "Power 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_info": "Power F2\nUDI-DI 00190790006570\nFirmware versions: PF2 Carriage V0.51/V1.42, PF2 Rail V0.41, PF2 Connect V108\nSerial Numbers\n25C227687\n25C228205\n25C228204\n25C227690\n25C227691\n25C227692\n25C227688\n25C227689\n25C227695\n25C227700\n25C227698\n25C227699\n25C227702\n25C227703\n25C227704\n25C227696\n25C227701\n25C227710\n25C227708\n25C227711\n26C231799\n26C231800\n26C231801\n25C227709\n25C227707\n26C231797\n26C232002\n26C232004\n26C232007\n26C232005\n26C232008\n26C232009\n26C231798\n26C232010\n26C232006\n26C232011\n26C232374\n26C232377\n26C232375\n26C232379\n26C232378\n26C232382\n26C232717\n26C232715\n26C232380\n26C232384\n26C232710\n26C232713\n26C233032\n26C232381\n26C232712\n26C232718\n26C232716\n26C233035\n26C232714\n26C233033\n26C233038\n26C233041\n26C233090\n26C233040\n26C233039\n26C233037\n26C233092\n26C233036\n26C233091\n26C233094\n26C233111\n26C232711\n26C233098\n26C233097\n26C233095\n26C233096\n26C233115\n26C233114\n26C233099\n26C233113\n26C233112\n26C233117\n26C233443\n26C233119\n26C233120\n26C233118\n26C233444\n26C233451\n26C233450\n26C233449\n26C233452\n26C233692\n26C233694\n26C233693\n26C233697\n26C233699\n26C233696\n26C233701\n26C233700\n26C234074\n26C234078\n26C234072\n26C234073\n26C234076\n26C233698\n26C234077\n26C234079\n26C234080\n26C234081\n26C234082\n26C234083\n26C234071\n26C234084\n26C234085\n26C234087\n26C234086\n26C234088\n26C234356\n26C234346\n26C234353\n26C234566\n26C234352\n26C234357\n26C234361\n26C234359\n26C234355\n26C234350\n26C234362\n26C234630\n26C234363\n26C234364\n26C234649\n26C234639\n26C234632\n26C234634\n26C234631\n26C234635\n26C234648\n26C234641\n26C234640\n26C234644\n26C234646\n26C234642\n26C234647\n26C234799\n26C234797\n26C234800\n26C234805\n26C234812\n26C234567\n26C234807\n26C234801\n26C234806\n26C234810\n26C234804\n26C234808\n26C234811\n26C234814\n26C234636\n26C234809\n26C235037\n26C234813\n26C234815\n26C234816\n26C235036\n26C235045\n26C235047\n26C235048\n26C235044\n26C235046\n26C235041\n26C235049\n26C235050\n26C235052\n26C235053\n26C235054\n26C235139\n26C235135\n26C235137\n26C235055\n26C235136\n26C235138\n26C235143\n26C235134\n26C235141\n26C235142\n26C235140\n26C235144\n26C235147\n26C235151\n26C235149\n26C235150\n26C235146\n26C235148\n26C235145\n26C235152\n26C235431\n26C235429\n26C235433\n26C235432\n26C235434\n26C235438\n26C235437\n26C235436\n26C235443\n26C235446\n26C235444\n26C235445\n26C235686\n26C235447\n26C235687\n26C235700\n26C235693\n26C235696\n26C235688\n26C235692\n26C235695\n26C235697\n26C235698\n26C235699\n26C235702\n26C235694\n26C235705\n26C235701\n26C236027\n26C235703\n26C236029\n26C236030\n26C236032\n26C236035\n26C235704\n26C236028\n26C236038\n26C236039\n26C236037\n26C236042\n26C236036\n26C236034\n26C236033\n26C236040\n26C236041\n26C236026\n26C236107\n26C236109\n26C236110\n26C236043\n26C236044\n26C236045\n26C236105\n26C236108\n26C236106\n26C236116\n26C236119\n26C236113\n26C236112\n26C236244\n26C236121\n26C236245\n26C236122\n26C236123\n26C236246\n26C236250\n26C236255\n26C236118\n26C236247\n26C236729\n26C236124\n26C236254\n26C236257\n26C236258\n26C236249\n26C236260\n26C236262\n26C236734\n26C236256\n26C236728\n26C236735\n26C236731\n26C236736\n26C236732\n26C236733\n26C236737\n26C236741\n26C236746\n\nPower X2\nUDI-DI 00190790003210 (Power X2) and 00190790006600 (PowerX2 Premium)\nFirmware versions PX2 V1.11/V1.18\nSerial Numbers 25G036128\n25G036612\n25G036614\n25G036801\n25G036802\n25G036803\n25G036804\n25G036827\n25G036830\n25G036833\n25G036834\n25G036835\n25G036837\n25G036836\n25G036953\n25G036954\n25G036958\n25G036959\n25G036960\n25G036961\n25G036962\n25G036963\n25G036964\n25G037067\n25G037068\n25G037071\n25G037094\n25G037072\n25G037095\n25G037098\n25G037100\n25G037161\n25G037163\n25G037217\n25G037225\n25G037226\n25G037227\n25G037228\n25G037229\n25G037285\n25G037289\n25G037288\n25G037298\n25G037299\n25G037305\n25G037338\n25G037342\n25G037337\n25G037466\n25G037467\n25G037468\n25G037470\n25G037471\n25G037472\n25G037473\n25G037474\n25G037526\n25G037596\n25G037595\n25G037623\n25G037665\n25G037691\n25G037692\n25G037705\n25G037707\n25G037703\n25G037704\n25G037706\n25G037713\n25G037770\n25G037772\n25G037774\n25G037780\n25G037781\n25G037782\n25G038074\n25G038075\n25G038076\n25G038080\n25G038081\n25G038082\n25G038079\n25G038083\n25G038084\n25G038536\n25G038088\n25G038539\n25G038540\n25G038615\n25G038616\n25G038617\n25G038618\n25G038625\n25G038627\n25G038578\n25G038626\n25G038619\n25G038765\n25G038767\n25G038766\n25G038768\n25G038769\n25G038948\n25G038991\n25G039003\n25G039001\n25G039002\n25G039004\n25G039005\n25G039068\n25G039069\n25G039070\n25G039065\n25G039066\n25G039067\n25G039072\n25G039071\n25G039073\n25G039189\n25G039188\n25G039191\n25G039192\n25G039193\n25G039210\n25G039248\n25G039249\n25G039190\n25G039350\n25G039653\n25G039720\n25G039728\n25G039724\n25G039725\n25G039726\n25G039727\n25G039728\n25G039737\n25G039730\n25G039732\n25G039738\n25G039729\n25G039754\n25G039736\n25G040014\n25G040015\n25G040016\n25C227713\n25C227714\n25G039773\n25G040077\n25G040078\n25G040079\n25G039774\n25G039776\n25G040073\n25G040074\n25G039775\n25G040075\n25G040076\n25G039878\n25G039879\n26G046003\n26G046004\n26G046005\n26G046006\n25G039777\n25G039872\n25G040062\n26G046007\n26G046008\n26G046009\n26G046010\n26G046011\n26G046012\n26G046013\n26G046014\n26G046015\n26G046049\n26G046051\n26G046052\n25G039881\n26G046048\n26G046111\n26G046050\n25G039779\n25G039882\n25G040061\n26G046045\n26G046046\n26G046110\n26G046112\n26G046113\n25G039880\n26G046047\n26G046105\n25G040070\n26G046016\n26G046103\n26G046106\n26G046109\n25G040067\n25G040069\n25G040071\n25G040072\n26G046236\n26G046237\n26G046239\n25G040068\n26G046238\n26G046240\n26G046265\n26G046266\n26G046267\n26G046268\n26G046269\n26G046313\n26G046318\n26G046319\n26G046320\n26G046321\n26G046310\n26G046311\n26G046312\n26G046314\n26G046315\n26G046316\n26G046317\n26G046336\n26G046322\n26G046334\n26G046335\n26G046324\n26G046401\n26G046389\n26G046388\n26G046390\n26G046393\n26G046396\n26G046397\n26G046398\n26G046399\n26G046400\n26G046455\n26G046458\n26G046459\n26G046391\n26G046394\n26G046454\n26G046456\n26G046457\n26G046460\n26G046461\n26G046387\n26G046392\n26G046395\n26G046629\n26G046630\n26G046631\n26G046632\n26G046633\n26G046634\n26G046635\n26G046636\n26G046637\n26G046638\n26G046721\n26G046722\n26G046583\n26G046855\n26G046580\n26G046581\n26G046646\n26G046774\n26G046802\n26G046805\n26G046806\n26G046803\n26C234762\n26C234763\n26C234764\n26C234765\n26C234766\n26C234767\n26G046808\n26C234770\n26C234771\n26G046582\n26G046647\n26G046723\n26G046801\n26G046804\n26G046807\n26G046818\n26C234768\n26G046775\n26G046819\n26G046820\n26G046821\n26G046822\n26G046856\n26G046857\n26G046859\n26G046884\n26G046882\n26G046883\n26G046885\n26G046858\n26G046887\n26G046888\n26G046907\n26G046908\n26G046909\n26G046910\n26G046911\n26G046927\n26G046928\n26G046923\n26G046924\n26G046925\n26G046987\n26G046988\n26G046989\n26G046886\n26G046926\n26G046929\n26G046984\n26G046985\n26G046982\n26G046983\n26G046986\n26G047001\n26G046996\n26G046997\n26G046998\n26G046999\n26G047002\n26G047003\n26G047004\n26G047066\n26C236801\n26G047008\n26G047009\n26G047012\n26G047013\n26C236726\n26C236727\n26G047000\n26G047010\n26G047014\n26G047011\n26G047059\n26G047060\n26G047061\n26G047062\n26G047099\n26C236723\n26C236725\n26G047063\n26G047064\n26G047097\n26C236803\n26C236804\n26C236722\n26C236802\n26C236805\n26C236806\n26C236807\n26C236840\n26C236841\n26C236724\n26C236842\n26C236843\n26C236844\n26C236854\n26C236932\n26C236935\n26C236857", "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": "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.", "root_cause_description": "Software design", "action": "Firm began notifying customers on April 28, 2026.\n\nCustomers 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.\n\nInstruction to Customers: \nUntil your Power F2 system has been updated: \n- continue to use the device in accordance with the instructions for use\n- if powered functionality is not available, transition to manual operation as needed\n-ensure personnel are familiar with manual operations procedures", "product_quantity": "319", "distribution_pattern": "Worldwide - 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.", "openfda": { "k_number": [ "K843439", "K861410", "K863083", "K113598", "K874332", "K942948", "K952447", "K955766", "K881845", "K854304", "K932260", "K072598", "K844578", "K946101", "K853421", "K935297", "K961437", "K792570", "K962181", "K840124", "K943528", "K933071", "K904011", "K871556", "K840125", "K862441", "K922809", "K920704", "K923730", "K840920", "K922808", "K933366", "K840122", "K884759", "K895740", "K873181", "K902503", "K862959", "K943864", "K943529", "K761147", "K864269", "K945431", "K943262", "K933060", "K801935", "K943969", "K914543", "K972528", "K900872" ], "registration_number": [ "3012330365", "2024242", "3009688852", "3011719874", "3008881803", "1043549", "3004198457", "3017181414", "3014101053", "3014270896", "3027847726", "3013964848", "3007802293", "3008386649", "3007836437", "3016678414", "3031582440", "3007662999", "3010509576", "3013408788", "3007420694", "3011659880", "3031563141", "2183191", "3007744192", "2428983", "3005206084", "3042991836", "3038141559", "3006513362", "3005706637", "2183887", "3020460367", "3007583774", "1824206", "3005878604", "1931947", "3006554931", "3015223105", "3043654660", "3006891315", "9681454", "3002818647", "3026311463", "9613910", "3005070829", "3006897996", "3006123327", "3014739961", "1721113", "3008058231", "3017884063", "3033849261", "3008975187", "3003674698", "1523574", "3011537487", "3017844600", "3045752744", "3003749961", "3002668219", "9615386", "2020676", "8010652", "1033902", "3011910987", "3021559257", "3030488262", "2184033", "3045978136", "3013856565", "3008042739", "3007515312", "1831750", "3001947547", "3006342679", "1000211739", "1422399", "3037012186", "1000122786", "3009567010", "8022103", "3010373263", "3027332478", "3042262500", "3006157842", "8022752", "2518443", "3004499949", "3009222501", "3008434522", "3011574775", "3017421556", "3003770834", "1528440", "8030903", "2027797", "3007123908", "3006697241", "3009171220", "3020978037", "3009238346", "3038197284", "3006750986", "3030927791", "3010703925", "3006554924", "3006975482", "3007912863", "3017708892" ], "fei_number": [ "3012330365", "2024242", "3009688852", "3011719874", "3008881803", "1000143830", "1043549", "3004198457", "3017181414", "3014101053", "3014270896", "3027847726", "1000125727", "3013964848", "2427360", "3007802293", "3008386649", "3007836437", "3016678414", "3031582440", "3007662999", "3010509576", "1000122527", "3013408788", "3007420694", "3011659880", "3031563141", "2183191", "3007744192", "3005206084", "3042991836", "3038141559", "3006513362", "3005706637", "2183887", "3020460367", "3007583774", "1824206", "3005878604", "3006554931", "3015223105", "3043654660", "3006891315", "3002818647", "3026311463", "3005070829", "3006897996", "3000134760", "3006123327", "3014739961", "1721113", "3008058231", "3017884063", "3033849261", "3008975187", "3003674698", "1523574", "3011537487", "3017844600", "3045752744", "3003749961", "3002668219", "2020676", "1033902", "3002808508", "3011910987", "3021559257", "3030488262", "3045978136", "1841", "3013856565", "3004574120", "3008042739", "3007515312", "1831750", "3001947547", "3006342679", "1000211739", "3037012186", "1000118429", "1000122786", "3009567010", "3010373263", "3027332478", "3042262500", "3006157842", "2518443", "3004499949", "3009222501", "3008434522", "3011574775", "3017421556", "3003770834", "3003769112", "3002913923", "3007123908", "3006697241", "3002572935", "3009171220", "3020978037", "3009238346", "3038197284", "3006750986", "3030927791", "3010703925", "3006554924", "3006975482", "3007912863", "1000115792", "3017708892" ], "device_name": "Stretcher, Wheeled", "medical_specialty_description": "General Hospital", "regulation_number": "880.6910", "device_class": "2" } } ] }