{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "124374", "product_res_number": "Z-0564-2014", "event_date_initiated": "2013-11-21", "event_date_posted": "2013-12-24", "recall_status": "Terminated", "event_date_terminated": "2014-06-23", "res_event_number": "66976", "product_code": "OWB", "k_numbers": [ "K073346" ], "product_description": "Ziehm Vision C-Arm Interventional Fluoroscopic X-Ray System.\n\nMobile Fluoroscopic Imaging", "code_info": "9209 9277 9448 9584 9655 9211 9278 9459 9585 9656 9212 9279 9475 9586 9657 9214 9315 9478 9587 9658 9216 9316 9506 9588 9659 9217 9343 9514 9633 9660 9245 9352 9530 9634 9664 9246 9358 9531 9645 9665 9255 9376 9551 9646 9666 9256 9377 9562 9647 9672 9272 9404 9571 9653 97119273 9427 9582 9654 9728", "firm_fei_number": "2027299", "recalling_firm": "Ziehm Imaging Inc", "address_1": "6280 Hazeltine National Dr", "address_2": "Suite 100", "city": "Orlando", "state": "FL", "postal_code": "32822-5114", "additional_info_contact": "47-615-8560 Ext. 140", "reason_for_recall": "Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the emergency switch was changed from a standard component to just an option on the devices.", "root_cause_description": "Device Design", "action": "Ziehm Imaging sent an \"URGENT RECALL NOTICE\" letter dated November 22, 2013, to all affected customers. The letter identified the products the problem and the action needed to be taken by the customers. \n\nCustomers were advised and instructed to:\n\nYour Model and Serial number can be found on the product label attached to the side of the mobile C-arm Stand. Our records indicate that your facility has one or more of the products listed above that are being used in your facility.\nRecall of the product was initiated because according to our manufacturing documentation, the referenced device installed at your facility was not equipped with an emergency stopping device for vertical travel of the c-arm imaging assembly. To fully comply with applicable standards the referenced device must be retrofitted with an emergency stopping device identification and label.\n\nThe issue:\nAccording to our manufacturing documentation, the referenced device installed at\nyour facility was not equipped with an emergency stopping device.\nTo fully comply with applicable standards the referenced device must be retrofitted with an emergency stopping device. The manufacturer Ziehm Imaging GmbH advised customers they may continue to operate the affected device with caution until the correction has been carried out on-site. During this time Ziehm Imaging GmbH advises the operator to be aware of the following safety\nmeasures which may resolve the possibility of potentially hazardous situations by:\n\" Operating the power-off switch located either on the C-arm Stand top panel or on the monitor cart\n\" Removing the power cable from the wall outlet or,\n\" Activate the push-buttons for reverse vertical movement and keeping the pushbutton pressed until patient /operator is no longer in the risk zone or the device stops \n\nPlease alert all staff members working with the device to these potential hazardous situations, and familiarize them with all possibilities to resolve the hazardous situation", "product_quantity": "60 devices", "distribution_pattern": "USA (Nationwide) Distribution including the states of AK, AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MT, MA, MD, MI, MN, MN, MO,MS, NC ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Hawaii.", "openfda": { "k_number": [ "K231692", "K183109", "K251523", "K210900", "K171829", "K232344", "K021049", "K032761", "K240199", "K051064", "K212523", "K092004", "K200917", "K133278", "K202547", "K220946", "K173736", "K181550", "K982993", "K200074", "K212212", "K032046", "K252099", "K041931", "K212159", "K993037", "K160279", "K130893", "K230871", "K181670", "K260607", "K961105", "K182415", "K181407", "K190768", "K172180", "K150967", "K061173", "K212383", "K092438", "K222998", "K141979", "K163286", "K181830", "K251893", "K193230", "K132094", "K171565", "K243303", "K172863", "K061953", "K242731", "K203551", "K133580", "K090590", "K052412", "K213479", "K172646", "K030061", "K152928", "K232298", "K220311", "K170130", "K092439", "K142126", "K223409", "K041605", "K200218", "K961374", "K241572", "K052202", "K024200", "K160455", "K220627", "K042053", "K173433", "K070834", "K142740", "K181415", "K221281", "K222080", "K203281", "K142243", "K190626", "K033244", "K240224", "K222070", "K132305", "K963952", "K201172", "K210055", "K212336", "K210307", "K251520", "K023178", "K033737", "K140138", "K120073", "K243328", "K112180", "K151000", "K091918", "K210054", "K153232", "K070123", "K010435", "K173639", "K122644", "K251827", "K142736", "K243646", "K253752", "K190064", "K202360", "K123508", "K043076", "K181966", "K200360", "K974355", "K253670", "K220342", "K022114", "K061163", "K030544", "K161563", "K133292", "K210912", "K213768", "K152697", "K033486", "K123529", "K093066", "K220432", "K100102", "K202431", "K170909", "K191503", "K102529", "K082243", "K250660", "K042793", "K101833", "K103416", "K131263", "K143225", "K254186", "K243884", "K181560", "K161976", "K012490", "K234067", "K254173", "K243735", "K163140", "K201743", "K200887", "K040675", "K223410", "K203504", "K254205", "K050489", "K183144", "K170752", "K171194", "K152785", "K210309", "K162148", "K240020", "K142273", "K082781", "K251602", "K122457", "K061203", "K052884", "K022322", "K233230", "K173664", "K153244", "K133535", "K132970", "K170832", "K181834", "K111551", "K201156", "K093688", "K222625", "K230950", "K992660", "K982427", "K102005", "K233748", "K041780", "K241567", "K221230", "K201583", "K231669", "K212557", "K200663", "K921219", "K992103", "K252503", "K234109", "K121444", "K083725", "K103425", "K022069", "K140041", "K062647", "K061534", "K000221", "K212813", "K183040", "K250282", "K253584", "K160147", "K170144", "K190497", "K011311", "K170800", "K062623", "K151904", "K031637", "K221344", "K120282", "K011292", "K172574", "K113403", "K172700", "K221516", "K180473", "K252068", "K960920", "K211777", "K130638", "K002198", "K200022", "K122234", "K060259", "K230949", "K101868", "K221335", "K221922", "K970734", "K161756", "K252500", "K193326", "K002016", "K162859", "K231700", "K970063", "K211064", "K192182", "K211191", "K161839", "K151598", "K173314", "K250010", "K181804", "K160088", "K250241", "K143281", "K243432", "K183101", "K172822", "K133819", "K132027", "K243411", "K213455", "K181943", "K182546", "K053279", "K232420", "K132147", "K152696", "K233200", "K172307", "K073543", "K912448", "K121772", "K083545", "K211782", "K240099", "K171755", "K111344", "K203535", "K212956", "K252229", "K091658", "K923049", "K162614", "K132558", "K181767", "K243376", "K182086", "K010942", "K142708", "K252735", "K211780", "K251199", "K041932", "K230185", "K230787", "K243446", "K251992", "K203623", "K113027", "K173631", "K212442", "K080847", "K993687", "K233107", "K123226", "K141574", "K936180", "K231701", "K153147", "K163715", "K220409", "K240465", "K983069", "K081073", "K013608", "K181403" ], "registration_number": [ "", "3012624817", "3011950073", "8043933", "3005172103", "3026391023", "3009001657", "3012761544", "3010162973", "3043048939", "3012127758", "3013944123", "3012957335", "3031503890", "3003775006", "3008632256", "3014328942", "3011015597", "3008284470", "3027373189", "3023003446", "3014391847", "1052701", "3047842058", "3010703925", "1054713", "3014343100", "3036666444", "3018077344", "3033525987", "3035950510", "3006128100", "1225677", "3021559833", "3003768277", "3001722928", "3008044777", "3005843418", "3012631246", "3030691709", "9613445", "9681146", "3016619943", "3003202425", "3033527282", "3006972752", "1720753", "3011240766", "3012911444", "3010685285", "3004198450", "1000188474", "3009144915", "3011416394", "3021059265", "3006544299", "3010462278", "3015223550", "3042175844", "2247992", "1000181430", "2939520", "3005877899", "3018094310", "3015232217", "3011491794", "3033527770", "3015437189", "3005810333", "3000126629", "3021060474", "3008363989", "2027062", "9611343", "3017375271", "3004785967", "2243057", "3030412764", "1835251", "3009715136", "3013184485", "3030089787", "3008496839", "3016438694", "1047843", "3008253300", "3027339477", "3009196578", "3009077524", "3011713200", "3003477135", "3009963139", "3004754211", "3033525986", "3004977335", "3003935342", "3038614464", "3018596740", "3004026651", "3022378058", "3025394757", "3009973505", "1056553", "3011347852", "3003768251", "3036255956", "2133772", "9614698", "2031966", "1723170", "3019878714", "3010398867", "3015276088", "3012939903", "3021027284", "3014279513", "3005706667", "3002466018", "8030233", "2027467", "1037955" ], "fei_number": [ "", "3012624817", "3011950073", "3005172103", "3026391023", "1000284313", "3009001657", "3012761544", "3043048939", "3012127758", "3013944123", "3012957335", "3031503890", "3002807041", "3003775006", "3008632256", "3014328942", "3011015597", "3008284470", "3027373189", "3023003446", "3014391847", "3047842058", "3010703925", "3014343100", "3002808139", "1000517638", "3036666444", "3018077344", "3033525987", "3035950510", "3006128100", "1000582291", "3021559833", "3001722928", "3008044777", "3005843418", "3012631246", "3030691709", "3016619943", "3003202425", "3033527282", "3006972752", "1720753", "3011240766", "3012911444", "3010685285", "3004198450", "1000188474", "3009144915", "1000208827", "3000209794", "3011416394", "3021059265", "3006544299", "3010462278", "3015223550", "1000132370", "3042175844", "1000181430", "2939520", "3005877899", "3018094310", "3015232217", "3011491794", "3002808382", "3033527770", "3015437189", "1000114111", "3005810333", "3000126629", "3021060474", "3008363989", "2027062", "3017375271", "3004785967", "2243057", "3030412764", "3009715136", "3013184485", "3030089787", "3008496839", "3016438694", "1047843", "3008253300", "3027339477", "3009196578", "3009077524", "3011713200", "3003477135", "3009963139", "3004754211", "3033525986", "3004977335", "3003935342", "3038614464", "3005430103", "3018596740", "3000205591", "3022378058", "3025394757", "3009973505", "3002175190", "3011347852", "3003768251", "3036255956", "3002807880", "3002619595", "3019878714", "1000222289", "3010398867", "3015276088", "3001451453", "3002980729", "3012939903", "3021027284", "3014279513", "3005706667", "3002466018", "2027467", "1037955" ], "device_name": "Interventional Fluoroscopic X-Ray System", "medical_specialty_description": "Radiology", "regulation_number": "892.1650", "device_class": "2" } } ] }