{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "160428", "product_res_number": "Z-0258-2018", "event_date_initiated": "2017-08-31", "event_date_created": "2018-01-09", "recall_status": "Terminated", "event_date_terminated": "2021-04-21", "res_event_number": "78784", "product_code": "OXO", "k_numbers": [ "K051754" ], "product_description": "Mobile Mini C-arm system Part # 1000-0001. \n\nIntended to provide the physician with general fluoroscopic visualization of the patient, including, but not limited to, surgical orthopedic procedures and critical and emergency care procedures.", "code_info": "Serial Number List:  Model # 1000-0001 5A217\t5D528\t5D566\t5D608\t5D647\t5D682 5C407\t5D529\t5D567\t5D609\t5D648\t5D683 5C417\t5D530\t5D568\t5D610\t5D649\t5D684 5C423\t5D531\t5D569\t5D611\t5D650\t5D685 5C427\t5D532\t5D570\t5D612\t5D651\t5D686 5C428\t5D533\t5D571\t5D613\t5D652\t5D687 5D501\t5D534\t5D572\t5D614\t5D653\t5D690 5D503\t5D535\t5D573\t5D615\t5D654\t5D694 5D504\t5D536\t5D574\t5D616\t5D655\t5D695 5D505\t5D537\t5D575\t5D620\t5D656\t5D696 5D506\t5D538\t5D576\t5D621\t5D657\t5D697 5D507\t5D539\t5D577\t5D622\t5D658\t5D698 5D508\t5D540\t5D578\t5D623\t5D659\t5D702 5D509\t5D541\t5D582\t5D626\t5D660\t5D703 5D510\t5D542\t5D587\t5D627\t5D661\t5D704 5D512\t5D543\t5D588\t5D628\t5D662\t5D705 5D513\t5D544\t5D589\t5D629\t5D663\t5D706 5D514\t5D545\t5D591\t5D630\t5D665\t5D708 5D515\t5D546\t5D592\t5D631\t5D666\t5D709 5D516\t5D547\t5D593\t5D632\t5D667\t5D710 5D517\t5D548\t5D594\t5D633\t5D668\t5D712 5D518\t5D549\t5D595\t5D634\t5D669\t5D714 5D519\t5D550\t5D596\t5D635\t5D670\t5D715 5D520\t5D552\t5D597\t5D636\t5D671\t5D716 5D521\t5D554\t5D598\t5D637\t5D673\t5D717 5D522\t5D555\t5D599\t5D638\t5D674\t5D720 5D523\t5D556\t5D600\t5D639\t5D675\t5D722 5D524\t5D562\t5D604\t5D640\t5D676\t5D723 5D525\t5D563\t5D605\t5D641\t5D677\t5D725 5D526\t5D564\t5D606\t5D643\t5D679\t5D726 5D527\t5D565\t5D607\t5D646\t5D680\t5D727 5A201\t5A220\t5B316\t5B324\t5C407\t5C418 5A202\t5B303\t5B317\t5B326\t5C408\t5C420 5A203\t5B307\t5B318\t5C401\t5C409\t5C424 5A204\t5B309\t5B319\t5C402\t5C411\t5C427 5A210\t5B313\t5B320\t5C403\t5C413\t5C428 5A217\t5B314\t5B322\t5C405\t5C414\t5C429 5A218\t5B315\t5B323\t5C406\t5C415\t5C430", "firm_fei_number": "3005254598", "recalling_firm": "Orthoscan, Inc.", "address_1": "8212 E Evans Rd", "city": "Scottsdale", "state": "AZ", "postal_code": "85260-3670", "additional_info_contact": "National Customer Service\n866-949-4346", "reason_for_recall": "OrthoScan Inc. discovered during investigation of a non-standard work flow a non-conformity of the devices. Specifically, the system software allows a user to activate the Digital Zoom feature in the course of taking a live image exposing a larger x-ray field than can be viewed by the user", "root_cause_description": "Software design", "action": "Orthoscan sent an Urgent Recall Notice, dated August 30, 2017, to customers, informing them of the issue and how to address it. Customers are to use the attached list of serial numbers to determine if their device is affected. Customers may continue to use their affected device with caution until the on-site correction has been made. Users should avoid non-conforming workflows by taking the measures outlined in the letter. The firm will contact customers to arrange implementation of the corrective action at no cost to the customer. If there are further questions or concerns, please call National Customer Service Team at (866) 949-4346.", "product_quantity": "2012 total", "distribution_pattern": "Worldwide Distribution - USA (nationwide) including Puerto Rico and Hawaii and to the countries of : Australia, Austria, Belgium, Canada, Dominican Republic, Estonia , Finland, France, Germany, Hanover, Hong Kong, Israel, Italy, Japan, Jonesboro, Korea, Malaysia. Netherland, New Zealand, Norway, Poland, Russia, Saudi Arabia, Spain, Sweden, Switzerland, Taiwan, UAE, and United Kingdom.", "openfda": { "k_number": [ "K010393", "K190024", "K003568", "K061873", "K051133", "K910115", "K940294", "K820658", "K900194", "K893617", "K935580", "K900193", "K253269", "K926056", "K934700", "K033066", "K172550", "K120388", "K880518", "K240828", "K120613", "K953910", "K896387", "K170946", "K911739", "K982706", "K892934", "K040066", "K183220", "K251004", "K243452", "K013426", "K993092", "K963093", "K913525", "K914748", "K253296", "K113708", "K213113", "K965013", "K233669", "K984406", "K760429", "K252579", "K250587", "K933431", "K973598", "K160131", "K092564", "K900967", "K933447", "K051754", "K951765", "K051490", "K163429", "K041213", "K203346", "K121303", "K003837", "K123603", "K921255", "K171800", "K131423", "K141672", "K182626", "K151280", "K960198", "K160065", "K133174", "K980322", "K050996", "K043379", "K040347", "K003266", "K060344", "K981131", "K192819", "K160984", "K955251", "K960907", "K010762", "K992506" ], "registration_number": [ "9613445", "3005877899", "3010462278", "3010703925", "3027339477", "1720753", "9611343", "3005172103", "3005843418", "3013099020", "3009715136", "3015223550", "3016619943", "3011491794", "1054713", "3018094310", "3008044777", "3027373189", "3010162973", "3008284470", "3021060474", "1723170", "3033525987", "3015276088", "3005496266", "1037955", "3005254598", "3018077344", "3006544299", "3004977335", "3003477135", "1222780", "3014279513", "3003768277", "3009196578", "3004198450", "3043048939", "3008496839", "3023003446", "3000126629", "3010685285", "3036666444", "3012624817", "3003202425", "3011416394", "9681146", "3003600763", "3005810333", "3008632256", "3011347852", "3017375271", "3009001657", "3012939903", "3035950510", "1225677", "8030233", "3011713200", "3010009632", "3036255956", "3030089787", "3010398867", "3031503890", "3004785967", "3012127758", "3042175844", "3015437189", "3021059265", "3002466018" ], "fei_number": [ "3001451453", "3005877899", "3010462278", "3010703925", "3027339477", "1720753", "3005172103", "3005843418", "3013099020", "3009715136", "3015223550", "3016619943", "3011491794", "3018094310", "3008044777", "3027373189", "1000114111", "1000284313", "3008284470", "3021060474", "3005254598", "3033525987", "3015276088", "3005496266", "1037955", "3018077344", "3006544299", "3004977335", "3003477135", "3014279513", "3002807041", "3009196578", "3004198450", "3043048939", "3008496839", "3023003446", "3000126629", "3010685285", "3002808139", "3012624817", "3036666444", "3003202425", "3002466018", "1000120743", "3011416394", "3002807880", "3003600763", "3005810333", "3008632256", "3011347852", "3017375271", "3009001657", "3012939903", "3035950510", "3011713200", "3010009632", "3005430103", "3036255956", "1000517638", "3030089787", "3010398867", "3031503890", "3004785967", "3012127758", "3042175844", "3015437189", "3021059265", "3002175190" ], "device_name": "Image-Intensified Fluoroscopic X-Ray System, Mobile", "medical_specialty_description": "Radiology", "regulation_number": "892.1650", "device_class": "2" } } ] }