{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "124375", "product_res_number": "Z-0565-2014", "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(2) C-Arm Interventional Fluoroscopic X-Ray System.\r\n\r\nMobile Fluoroscopic Imaging", "code_info": "9760 9937 90067 90816 9763 9945 90102 90817 9828 9946 90103 90819 9840 9983 90142 90823 9841 9985 90636 90838 9848 9986 90699 90842 9849 90024 90715 90863 9855 90031 90750 90864 9856 90032 90758 90865 9894 90033 90773 90899 9896 90034 90774 90909 9923 90054 90813 90919 9924 90065 90814 9936 90066 90815", "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. \r\n\r\nCustomers were advised and instructed to:\r\n\r\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.\r\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.\r\n\r\nThe issue:\r\nAccording to our manufacturing documentation, the referenced device installed at\r\nyour facility was not equipped with an emergency stopping device.\r\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\r\nmeasures which may resolve the possibility of potentially hazardous situations by:\r\n\" Operating the power-off switch located either on the C-arm Stand top panel or on the monitor cart\r\n\" Removing the power cable from the wall outlet or,\r\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 \r\n\r\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": "54 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": [ "K133580", "K022069", "K982993", "K240099", "K222080", "K254173", "K093066", "K221922", "K252735", "K002016", "K123508", "K013608", "K142736", "K113027", "K181943", "K130638", "K060259", "K200917", "K070834", "K170752", "K120073", "K103425", "K936180", "K181670", "K030544", "K183144", "K201172", "K041605", "K251199", "K252068", "K190768", "K221281", "K212159", "K243328", "K200022", "K152696", "K212557", "K260607", "K251523", "K142126", "K211191", "K133292", "K961374", "K190064", "K152697", "K923049", "K221335", "K240465", "K252229", "K211782", "K241572", "K921219", "K000221", "K240224", "K160279", "K200887", "K222070", "K183101", "K122234", "K211064", "K111551", "K203281", "K093688", "K082243", "K143225", "K203504", "K181966", "K083725", "K031637", "K223410", "K053279", "K152785", "K243411", "K190626", "K133535", "K142273", "K201743", "K201583", "K222625", "K180473", "K153244", "K193230", "K220432", "K220409", "K061953", "K043076", "K030061", 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"medical_specialty_description": "Radiology", "regulation_number": "892.1650", "device_class": "2" } } ] }