{ "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": "2026-10-29", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "223114", "product_res_number": "Z-0286-2027", "event_date_initiated": "2026-09-03", "event_date_posted": "2026-10-23", "recall_status": "Open, Classified", "res_event_number": "99979", "product_code": "OXO", "k_numbers": [ "K243452" ], "product_description": "Orthoscan VERSA Accessory Cart, REF: 1000-0021 and Versa Mini C-Arm System, REF: 1000-0020", "code_info": "UDI/ Mini C-Arm serial number (6Axxxx)/Accessory cart serial Number: (VCXXX):\n\n1 6A0110 /VC0110\n2 6A0111 /VC0111\n3 6A0112 /VC0112\n4 6A0115 /VC0113\n5 6A0114 /VC0114\n6 6A0117 /VC0115\n7 6A0116 /VC0116\n8 6A0113 /VC0117\n9 6A0118 /VC0118\n10 6A0119/ VC0119, VC0120;\n11 6A0120 /VC0121;\n12 6A0121 /VC0122;\n13 6A0123 /VC0123;\n14 6A0122 /VC0124;\n15 6A0126 /VC0125;\n16 6A0133 /VC0134;\n17 6A0124 /VC0126;\n18 6A0128 /VC0128;\n19 6A0127 /VC0129;\n20 6A0129 /VC0130;\n21 6A0125 /VC0127;\n22 6A0131 /VC0132;\n23 6A0134 /VC0133;\n24 6A0142 /VC0144;\n25 6A0136 /VC0136;\n26 6A0132 /VC0137;\n27 6A0137 /VC0138;\n28 6A0138 /VC0139;\n29 6A0139 /VC0140;\n30 6A0140 /VC0141;\n31 6A0141 /VC0142;\n32 6A0146 /VC0147;\n33 6A0143 /VC0143;\n34 6A0144 /VC0145;\n35 6A0152 /VC0153;\n36 6A0147 /VC0148;\n37 6A0148 /VC0149;\n38 6A0149 /VC0150;\n39 6A0150 /VC0151;\n40 6A0151 / VC0152;\n41 6A0163 / VC0165;\n42 6A0130 / VC0131;\n43 6A0155 / VC0156;\n44 6A0157 / VC0157;\n45 6A0156/ VC0158;\n46 6A0158 / VC0159, VC0160;\n47 6A0159/ VC0161;\n48 6A0160/ VC0162;\n49 6A0161 / VC0163;\n50 6A0162 VC0164;\n51 6A0153 VC0154;\n52 6A0164 VC0166;\n53 6A0165 VC0167", "firm_fei_number": "3017541298", "recalling_firm": "ZIEHM-ORTHOSCAN INC", "address_1": "14555 N 82nd St", "city": "Scottsdale", "state": "AZ", "postal_code": "85260-2525", "additional_info_contact": "Kevin Bridgman\n480-5038010", "reason_for_recall": "The accessory cart weldment does not conform to weld dimensional specifications which may result in separation of the monitor arm mounting structure from the cart.", "root_cause_description": "Process control", "action": "On September 11, 2026, Ziehm-Orthoscan issued a Urgent: Medical Device Recall Notification via Email. Ziehm-Orthoscan ask consignees to take the following actions:\n\n1. The device may continue to be used until the corrective action has been completed, provided the user follows the precautions described in this notification and no signs of instability or unintended movement are observed.\n\n2. Users should exercise caution when positioning, moving, or operating the system and monitor assembly, avoid fully extending the display arm until the corrective action has been performed.\n\n3. If unintended movement, instability, loosening, or any other condition related to the issue described in this notification is observed, discontinue use of the affected system and contact Ziehm- Orthoscan immediately for further instructions.\n\n4. Please ensure that a copy of this notification is made available to all users and operators of the affected device. It is recommended that this notification be posted in a visible location near the device until the corrective action has been completed.\n\n5. If the affected device has been transferred, sold, or relocated to another facility or department, please ensure that a copy of this notification is provided to the current user or owner of the device.\n\n6. Please maintain awareness of this notification until the corrective action has been completed and verified by Ziehm-Orthoscan or its authorized representative.", "product_quantity": "55 units", "distribution_pattern": "Worldwide - US Nationwide distribution in the states of AZ , CA , CO , CT , FL , GA , IL , IN , KS, MA , MD , MI , MN , NC , NE , NV , NY , OH , OR , SC, TX , UT , WA and the countries of Germany , Australia , Spain , Switzerland, Japan.", "openfda": { "k_number": [ "K933431", "K040347", "K960907", "K051133", "K893617", "K940294", "K160065", "K951765", "K131423", "K013426", "K914748", "K233669", "K982706", "K123603", "K980322", "K900967", "K003837", "K960198", "K240828", "K953910", "K880518", "K913525", "K243452", "K250587", "K900194", "K171800", "K993092", "K213113", "K910115", "K253296", "K984406", "K133174", "K981131", "K151280", "K172550", "K820658", "K892934", "K973598", "K033066", "K251004", "K050996", "K043379", "K061873", "K190024", "K253269", "K252579", "K040066", "K183220", "K896387", "K203346", "K010393", "K051754", "K992506", "K003568", "K113708", "K010762", "K963093", "K120388", "K051490", "K160131", "K934700", "K170946", "K965013", "K935580", "K092564", "K182626", "K160984", "K955251", "K060344", "K141672", "K121303", "K900193", "K163429", "K120613", "K926056", "K003266", "K933447", "K911739", "K041213", "K192819", "K760429", "K921255" ], "registration_number": [ "", "3011416394", "3009715136", "3027373189", "3033525987", "3000126629", "9681146", "1720753", "3004785967", "3035950510", "1225677", "3043048939", "3016619943", "3031503890", "3030089787", "1222780", "3002466018", "3042175844", "3003477135", "3017375271", "3036666444", "3021060474", "3013099020", "3010009632", "3005496266", "3027339477", "3015437189", "3021059265", "1054713", "9613445", "3015223550", "3011713200", "3004977335", "3018077344", "3005172103", "3008044777", "3010685285", "1723170", "3033527282", "3009196578", "3006544299", "3003600763", "3023003446", "3010703925", "3018094310", "8030233", "3003202425", "3012127758", "3009001657", "3015276088", "3036255956", "3008284470", "3005254598", "3008496839", "3012624817", "3012939903", "1037955", "3005810333", "3011347852", "9611343", "3014279513", "3004198450", "3010162973", "3010398867", "3003768277", "3014134519", "3010462278", "3005877899", "3008632256", "3011491794", "3005843418" ], "fei_number": [ "", "3002807880", "3011416394", "3009715136", "3027373189", "3033525987", "3000126629", "1720753", "3004785967", "3002808139", "3035950510", "3043048939", "3002175190", "3016619943", "3031503890", "3030089787", "1000120743", "3002466018", "3042175844", "3003477135", "3017375271", "3036666444", "3021060474", "3013099020", "3010009632", "3001451453", "3005496266", "3015437189", "3021059265", "3027339477", "3015223550", "3004977335", "3011713200", "3005172103", "3018077344", "3008044777", "3010685285", "3033527282", "3009196578", "3006544299", "3003600763", "3023003446", "3010703925", "3018094310", "3003202425", "3012127758", "1000284313", "3009001657", "3015276088", "3036255956", "3008284470", "3005254598", "3008496839", "3012624817", "3012939903", "1037955", "1000517638", "3005810333", "3011347852", "3002807041", "3014279513", "3005430103", "3004198450", "1000114111", "3010398867", "3014134519", "3010462278", "3005877899", "3008632256", "3011491794", "3005843418" ], "device_name": "Image-Intensified Fluoroscopic X-Ray System, Mobile", "medical_specialty_description": "Radiology", "regulation_number": "892.1650", "device_class": "2" } } ] }