{ "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": "124607", "product_res_number": "Z-0796-2014", "event_date_initiated": "2013-11-25", "event_date_posted": "2014-01-21", "recall_status": "Terminated", "event_date_terminated": "2016-06-30", "res_event_number": "67047", "product_code": "IZL", "k_numbers": [ "K091889" ], "product_description": "DRX-Evolution with FF WS\n\nThese products are permanently installed diagnostic x-ray systems composed of 4 main components: an operator console, over head tube crane, x-ray tube assembly including a collimator and stationary generator. In addition the device can use an x-ray table and /or wallstand/bucky to complete x-ray exposures. The DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions.", "code_info": "Service Code: 7171", "firm_fei_number": "1317307", "recalling_firm": "Carestream Health, Inc.", "address_1": "1049 Ridge Rd W", "city": "Rochester", "state": "NY", "postal_code": "14615-2731", "additional_info_contact": "585-781-1997", "reason_for_recall": "Carestream Health Inc. has issued a recall for the Carestream DRX-Evolution (FF WS and CSJ WS) and the Kodak DirectView DR 7500 System due to the potential for unexpected device movement.", "root_cause_description": "Nonconforming Material/Component", "action": "The firm, Carestream Health Inc, sent an \"URGENT: Medical Device Recall\" notice dated November 20, 2013 to their customers. The notice described the product, problem and actions to be taken. The customers were instructed that the Emergency Stop (E-Stop) button be used on the motorized FF WS and CSH WS Buckys for any observed uncontrolled movement as indicated in the user guide. If this movement is observed, please notify Carestream Health, and Carestream will schedule a site visit to resolve the problem. In addition, Carestream Health Inc. will apply a label(s) indicating the location of the E-stop button for customers using the FF WS. \n\nIf you have any questions or concerns, please contact the Carestream Customer Care Center in the U.S. at 1-800-328-2910.", "product_quantity": "675 units Total (145 units domestically & 530 units internationally)", "distribution_pattern": "Worldwide Distribution: US (nationwide) including states of: CA, CO, FL, GA, IL,IN, MD, MI, MN, NC, ND, NJ, NY, OH, OK, PA, SC, SD, TN, TX, VA, WA, and WI; and internationally to: Australia Belgium, Canada, China, Finland, France, Germany, Hong Kong, Italy, Netherlands, New Zealand, Poland, Portugal, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, and United Kingdom.", "openfda": { "k_number": [ "K911841", "K781975", "K030494", "K240009", "K931483", "K781676", "K192936", "K850678", "K970234", "K141885", "K240841", "K260085", "K161345", "K182639", "K212654", "K061685", "K103522", "K810276", 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"K182207", "K041763", "K250750", "K202353", "K173602", "K222353", "K212291", "K202350", "K062472", "K201340", "K212515", "K790393", "K052341", "K921425", "K213405", "K243473", "K210479", "K183292", "K191813", "K953292", "K944442", "K111725", "K250597", "K912323", "K902610", "K212134", "K972204", "K052897", "K153059", "K042361", "K790392", "K210982", "K141895", "K894643", "K203667", "K241996", "K100449", "K934818", "K941363", "K260236", "K173299", "K042368", "K100400", "K862452", "K200976", "K955036", "K080945", "K090322", "K060566", "K021016", "K875106", "K222258", "K790451", "K253185", "K930049", "K090655", "K072392", "K770903", "K203658", "K052001", "K780999", "K211383", "K162687", "K240284", "K241980", "K212144", "K953404", "K910902", "K171119", "K171353", "K191451", "K973712", "K981466", "K781976", "K211423", "K833239", "K083048", "K101517", "K843192", "K020436", "K201488", "K041922", "K212940", "K930699", "K142492", "K894021", "K191884", "K811082", "K790673", "K251443", "K781425", "K251710", "K170755", "K181626", "K782155", "K122298", "K760741", "K242515", "K211473", "K932354", "K781705", "K200726", "K230581", "K002685", "K082627", "K890306", "K932106", "K191025", "K173018", "K071015", "K170607", "K122697", "K233678", "K251223", "K921116", "K924798", "K193535", "K203782", "K221803", "K222896", "K163063", "K241505", "K143494", "K162278", "K150097", "K162990", "K010304", "K790443" ], "registration_number": [ "9614430", "3012624817", "3006542593", "3011950073", "3015537309", "1219183", "3013779985", "3017944270", "9616047", "3009001657", "3015502499", "3012127758", "3023344919", "3004706313", "2126677", "3031503890", "3003775006", "3014809646", "3011015597", "3008284470", "3023003446", "3021006193", "9617251", "3009717300", "3014209556", "3002707445", "3018077344", "1225677", "1418484", "3016250464", "3001722928", "3008044777", "3010300212", "3018269927", "9613445", "2433615", "3006551157", "1418960", "3006051164", "3004606964", "3007734888", "3011416394", 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