{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 9 } }, "results": [ { "cfres_id": "139450", "product_res_number": "Z-0128-2016", "event_date_initiated": "2015-08-05", "event_date_posted": "2015-11-06", "recall_status": "Terminated", "event_date_terminated": "2017-03-22", "res_event_number": "71958", "product_code": "MUH", "k_numbers": [ "K111152" ], "product_description": "Villa Sistemi Rotograph EVO 3D X-ray", "code_info": "p/n 9307251291, 9307351291, 9307651291", "firm_fei_number": "2243757", "recalling_firm": "Villa Radiology Systems LLC", "address_1": "91 Willenbrock Rd Ste B1 91 Willenbrock Rd", "address_2": "Ste B1", "city": "Oxford", "state": "CT", "postal_code": "06478-1036", "reason_for_recall": "It has been discovered that due to lack of information accompanying documents the product fails to comply with 21CfR 1020.33(c),1020.33(d),1020.33(g),and 1020.330).", "root_cause_description": "Other", "action": "Villa Radiology Systems Planned Action:\r\n\r\n1. The current users manuals have been updated and addendums to the user manuals have been developed for currently installed Rotograph Evo\r\n3D and Imax Touch 3D. The revisions and addendums contain all information required under 21 CFR 1020.33(c), 1020.33(d), 1020.33(g), and\r\n1020.33(j).\r\n\r\n2. New Rotograph Evo 3D and Imax Touch 3D systems will ship with the updated user manual.\r\n\r\n3. Addendums will be provided to all end users\r\n\r\nCDRH approves the CAP subject to the following conditions:\r\n\r\n1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22.", "product_quantity": "Rotograph EVO 3D - 8 installed", "distribution_pattern": "US Distribution", "openfda": { "k_number": [ "K100960", "K191623", "K141700", "K122155", "K070664", "K061284", "K073365", "K041120", "K140013", "K111231", "K220556", "K024186", "K053220", "K203116", "K131442", "K181358", "K142995", "K150797", "K170733", "K042372", "K202633", "K160788", "K111103", "K080889", "K230732", "K110371", "K130585", "K113497", "K092537", "K123419", "K102124", "K070505", "K122918", "K041834", "K133271", "K232552", "K220423", "K133231", "K051664", "K012514", "K021542", "K072357", "K001439", "K090526", "K251206", "K061114", "K153060", "K013271", "K202664", "K073350", "K091866", "K090458", "K041580", "K110160", "K992385", "K082972", "K200284", "K231202", "K020588", "K120106", "K031801", "K090020", "K203374", "K013659", 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