{ "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": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "197697", "product_res_number": "Z-1040-2023", "event_date_initiated": "2022-12-16", "event_date_posted": "2023-01-30", "recall_status": "Open, Classified", "res_event_number": "91418", "product_code": "OWB", "k_numbers": [ "K181407" ], "product_description": "System\tMaterial #\nArtis zee floor \t10094135\nArtis zee ceiling \t10094137\nArtis zee multi-purpose\t10094139\nArtis zee biplane\t10094141\nArtis zeego\t10280959\nArtis Q floor\t10848280\nArtis Q ceiling\t10848281\nArtis Q biplane\t10848282\nArtis Q.zeego\t10848283\nArtis Q.zen floor\t10848353\nArtis Q.zen ceiling\t10848354\nArtis Q.zen biplane\t10848355\n\n\n\nFluoroscopic X-Ray System", "code_info": "Artis zee floor \tUDI-DI 4056869010045\nSerial Numbers 138481\n124714\n138390\n138497\n124709\n124395\n138102\n138071\n124383\n124706\n137617\n137607\n139133\n137752\n137736\n138325\n138358\n139120\n124378\n124713\n139127\n138397\n138367\n124703\n138070\n124388\n124708\n139012\n139023\n124724\n138340\n138051\n\n\nArtis zee ceiling \tUDI-DI 4056869010052\nSerial numbers\n150011\n150062\n148498\n150060\n150002\n147983\n150017\n148486\n148487\n148488\n125716\n148260\n148288\n147954\n125267\n125269\n147956\n147958\n147957\n147955\n148001\n148277\n125700\n147974\n150040\n125705\n147969\n148270\n150036\n150005\n148019\n147120\n147119\n148361\n150023\n148479\n147114\n125257\n125119\n148431\n148474\n150009\n150015\n148029\n147952\n148484\n148466\n148489\n125715\n150003\n150046\n150047\n125254\n148240\n148239\n\n\nArtis zee multi-purpose\tUDI-DI 4056869010076\nSerial numbers\n159088\n159190\n158650\n158652\n158742\n159124\n130241\n159157\n159030\n159085\n159117\n130714\n159034\n158225\n159156\n159038\n159181\n159032\n159046\n158183\n159175\n158272\n159054\n159099\n158519\n159177\n158495\n159015\n159127\n159058\n159028\n158744\n159147\n159037\n158206\n159132\n159026\n130708\n158180\n159041\n159176\n159042\n159152\n158638\n130720\n159158\n158597\n159168\n158211\n158458\n159180\n159047\n159025\n159024\n159192\n159021\n130715\n158468\n158678\n159182\n159148\n158786\n159113\n158658\n159102\n159100\n159080\n159079\n158510\n158227\n159049\n159065\n157702\n158599\n159010\n\n\nArtis zee biplane UDI-DI\t4056869010069\nSerial numbers\n154827\n155265\n131707\n155151\n156011\n154794\n156014\n154799\n154814\n155131\n155310\n155266\n131247\n155286\n153999\n131252\n\n\nArtis zeego\tUDI-DI 4056869010083\nSerial numbers\n161226\n161008\n161021\n161051\n161209\n161022\n161233\n161224\n\n\nArtis Q floor\tUDI-DI 4056869009971\nSerial numbers\n103218\n104049\n104007\n104016\n104005\n104061\n104027\n132508\n132510\n104051\n103030\n103258\n104012\n103384\n104029\n104020\n103008\n104025\n103222\n132507\n103230\n104047\n104062\n104013\n132502\n132509\n132500\n103048\n132000\n103245\n103348\n\n\nArtis Q ceiling\tUDI-DI 4056869009988\nSerial numbers\n110199\n110088\n110059\n110223\n110103\n133503\n110035\n110166\n110046\n110005\n109812\n109727\n110058\n110156\n110176\n110180\n110147\n109931\n110181\n110056\n110062\n110158\n109074\n109388\n109352\n110221\n133201\n133000\n109789\n110234\n110207\n110195\n110209\n109523\n109645\n109166\n110067\n110161\n109817\n110227\n110184\n110169\n110119\n110144\n110167\n110095\n109134\n109133\n109084\n110051\n109833\n110001\n110020\n110192\n109688\n110007\n110131\n109432\n109434\n110093\n110128\n110219\n109384\n109378\n109598\n109893\n110096\n109653\n109621\n109748\n110236\n109451\n133504\n109102\n109431\n109383\n109785\n109794\n110198\n109015\n110069\n110106\n110139\n109662\n110185\n110075\n110214\n109803\n109627\n109772\n110179\n110235\n110063\n110042\n110061\n110064\n110048\n110043\n110032\n110047\n110102\n110039\n110040\n110023\n110014\n110159\n110110\n110230\n110065\n109848\n110052\n109057\n110018\n110224\n109103\n109165\n110228\n110191\n110136\n110201\n110072\n109741\n109129\n110145\n109034\n109181\n109678\n110081\n110036\n110182\n110233\n110232\n110054\n109795\n109179\n109661\n109699\n109155\n110109\n109424\n110053\n110107\n109072\n109071\n110044\n110031\n109300\n110175\n110193\n110187\n110016\n110196\n109041\n110077\n110037\n109497\n109039\n110079\n110211\n110210\n110099\n110113\n110217\n109560\n110027\n110134\n110049\n110117\n110066\n110024\n109088\n110017\n110186\n110025\n109096\n109159\n109358\n110231\n110154\n110183\n110208\n109364\n110100\n110129\n110190\n110188\n110083\n110091\n109301\n110006\n110115\n109302\n109369\n110055\n109854\n109844\n109350\n109069\n109648\n109158\n110026\n110022\n109028\n109027\n109120\n110000\n109705\n109677\n110152\n133501\n109739\n110177\n110057\n109774\n110132\n110104\n109044\n133508\n110174\n110041\n109917\n133509\n110149\n110216\n\n\nArtis Q biplane\tUDI-DI 4056869009995\nSerial numbers\n121314\n122049\n122025\n121336\n122012\n122055\n121612\n122040\n122021\n122028\n121623\n122060\n122037\n122005\n121374\n121014\n121112\n121209\n121621\n121133\n121163\n122039\n121018\n121154\n121354\n122046\n121340\n121205\n122034\n121324\n121078\n122042\n134003\n121563\n122050\n121635\n121355\n121010\n121395\n121551\n121633\n121190\n134504\n121039\n121416\n121417\n122001\n121012\n121049\n134502\n134500\n122033\n121120\n121122\n121121\n122010\n121148\n122048\n122007\n121004\n122016\n121175\n121057\n121056\n121419\n121466\n122013\n121525\n121319\n121058\n121085\n121377\n121375\n121393\n121339\n121310\n121199\n122017\n134506\n121533\n122024\n122027\n121591\n121046\n121313\n122014\n\n\nArtis Q.zeego\tUDI-DI 4056869010007\nSerial numbers\n117316\n117108\n117125\n117020\n117123\n117117\n117304\n117310\n117303\n117113\n117014\n\n\nArtis Q.zen floor\tUDI-DI 4056869010014\nSerial numbers\n105110\n105500\n105007\n105503\n105018\n143500\n105135\n105501\n105142\n105017\n105123\n105121\n105122\n105112\n\nArtis Q.zen ceiling\tUDI-DI 4056869010021\n111502\n111517\n111523\n111503\n111005\n111002\n111510\n111527\n111507\n111512\n111508\n111521\n111133\n111529\n111524\n111504\n111526\n111513\n111010\n111175\n111528\n111506\n111525\n111500\n111501\n111169\n111505\n111166\n111107\n111514\n\nArtis Q.zen biplane\tUDI-DI 4056869010038\nSerial numbers\n123043\n123031\n123008\n123255\n123252\n123032\n123209\n123208\n123508\n123514\n123505\n123213\n123513\n123251\n123022\n123510\n123509\n123502\n123201\n123023\n123501\n123216\n123249\n123037\n123511\n123512\n123244", "firm_fei_number": "2240869", "recalling_firm": "Siemens Medical Solutions USA, Inc", "address_1": "40 Liberty Blvd", "city": "Malvern", "state": "PA", "postal_code": "19355-1418", "additional_info_contact": "Meredith Adams\n610-219-4834", "reason_for_recall": "In rare cases, the system may only boot into backup mode after an abrupt shutdown and not reach full operating mode. This may result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system.", "root_cause_description": "Software design", "action": "On December 16, 2022, the firm initiated the recall to its affected customers via Urgent Medical Device Correction letters. Customers were instructed to do the following:\n\nObserve if the system suffers an abrupt shutdown. This can be caused e.g., by usage of the Emergency SHUTDOWN button, manually switching off via End session / Shutdown System command in the main menu, or by a long press on the power-on push button on the system console.\nIn the event of an abrupt shutdown, restart immediately to verify system state and call service if necessary.\n\nThe firm will provide a software patch to affected systems. Siemens's service organization will contact customers to arrange a date to perform the corrective action. Please feel free to contact the service organization for an earlier appointment at 1-800-888-7436.", "product_quantity": "609 US; 1627 worldwide", "distribution_pattern": "Worldwide - US Nationwide distribution.", "openfda": { "k_number": [ "K221516", "K243376", "K231669", "K222625", "K040675", "K150967", "K241572", "K210900", "K243328", "K153244", "K123226", "K130893", "K210912", "K152697", "K030544", "K252099", "K160455", "K183109", "K091918", "K172574", "K160147", "K101833", "K052202", "K123508", "K210307", "K936180", "K213479", "K240465", "K190626", "K073543", "K220342", "K243646", "K051064", "K061163", "K234067", "K011292", "K213768", "K010435", "K251523", "K170909", "K230950", "K141979", "K111551", "K232344", "K162614", "K193230", "K111344", "K120282", "K201743", "K041931", "K200022", "K240199", "K251199", "K101868", "K203623", "K220409", "K122644", "K031637", "K182546", "K221335", "K042793", "K121444", "K233107", "K142708", "K100102", "K022069", "K250282", "K103416", "K974355", 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