{ "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": "2026-09-10", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "186123", "product_res_number": "Z-1281-2021", "event_date_initiated": "2021-03-03", "event_date_created": "2021-03-19", "recall_status": "Open, Classified", "res_event_number": "87471", "product_code": "MUJ", "k_numbers": [ "K200487" ], "product_description": "RayCare 3B (3.1.0.60341) - Product Usage: Intended Use Oncology information system that supports healthcare professionals in delivering cancer care.", "code_info": "S/N: 3.1.0.60341 Software: RayCare 3B (3.1.0.60341) UDI: 0735000201028020191220;", "firm_fei_number": "3007774465", "recalling_firm": "RAYSEARCH LABORATORIES AB", "address_1": "Sveavagen 9 9 sveavagen", "city": "Stockholm", "country": "Sweden", "reason_for_recall": "Patient related messages created in RayCare 3B, RayCare 4A will be lost when upgrading from RayCare 2 to RayCare 3B or later", "root_cause_description": "Software design", "action": "Raysearch issued via E-mail on 03 March 2021, Field Safety Notice, Medical Device Correction #75198 letter stating reason for recall, health risk and action to take: \nRaySearch will check if the issue affects your system and apply the below solution.\n\" Until the solution has been applied, be aware that the message body is missing from messages created in RayCare 2.\n\" Confirm you have read and understood this notice by replying to the notification email.\nFor regulatory information, please contact quality@raysearchlabs.com\n\nSOLUTION\nThis issue will be resolved by RaySearch staff using a support tool. Using the support tool, the message body will be restored to all messages in the currently used RayCare version.", "product_quantity": "1 unit", "distribution_pattern": "US Nationwide distribution in the state of TN.", "openfda": { "k_number": [ "K151233", "K193640", "K182665", "K202284", "K260207", "K083264", "K242378", "K082005", "K992434", "K990475", "K974770", "K190178", "K990071", "K151435", "K170969", "K192554", "K234068", "K062967", "K202789", "K233236", "K211841", "K090972", "K181145", "K211379", "K071938", "K252784", "K223279", "K143269", "K022411", "K240671", "K022036", "K151380", "K040474", "K020027", "K091145", "K051497", "K100092", "K013112", "K111311", "K141900", "K213787", "K102915", "K052325", "K020971", "K082606", "K252109", "K993923", "K083672", "K040688", "K100417", "K992753", "K032724", "K103246", "K022961", "K220141", "K010682", "K223233", "K201350", "K230557", "K101076", "K002132", "K012017", "K131428", "K991815", "K031349", "K081112", "K201607", "K991237", "K053584", "K001700", "K051941", "K241876", "K001295", "K260308", "K140187", "K223724", "K250963", "K180379", "K193459", "K123357", "K242748", "K183037", "K002240", "K151369", "K210645", "K993895", "K002237", "K203681", "K002312", "K071873", "K062514", "K090893", "K081281", "K062032", "K152488", "K182888", "K241318", "K013535", "K120363", "K141860", "K112776", "K250440", "K101119", "K982696", "K984196", "K093588", "K103093", "K173940", "K061440", "K061097", "K000922", "K090182", "K090531", "K151560", "K013661", "K201444", "K982791", "K983343", "K092132", "K915691", "K253091", "K050296", "K080601", "K252002", "K080929", "K222728", "K243057", "K992762", "K120551", "K142108", "K031281", "K002147", "K242992", "K232479", "K103515", "K002509", "K083414", "K112446", "K012575", "K193109", "K011246", "K150547", "K120387", "K203469", "K143514", "K071760", "K022307", "K984532", "K041971", "K101220", "K170086", "K010784", "K200608", "K180289", "K212274", "K092928", "K133655", "K041719", "K193381", "K222312", "K171536", "K151469", "K260750", "K141283", "K214081", "K151666", "K170355", "K110730", "K152393", "K213438", "K250064", "K061893", "K191384", "K022741", "K031088", "K013673", "K103146", "K121448", "K242822", "K253078", "K981678", "K100056", "K082221", "K091146", "K231825", "K222803", "K141248", "K220582", "K993675", "K123263", "K161136", "K013644", "K100552", "K133247", "K073020", "K151887", "K173635", "K041403", "K162370", "K083502", "K063482", "K042739", "K993766", "K113102", "K112060", "K102216", "K242463", "K171885", "K240398", "K042861", "K211034", "K082642", "K992864", "K041997", "K130617", "K090808", "K992303", "K021268", "K032345", "K190387", "K102011", "K211867", "K112723", "K132816", "K133331", "K211881", "K123152", "K153368", "K042269", "K253050", "K192065", "K093391", "K160093", "K211511", "K232799", "K252863", "K132971", "K080888", "K203766", "K091492", "K030821", "K220783", "K131891", "K200487", "K091179", "K063230", "K994413", "K032209", "K252304", "K172163", "K982821", "K200569", "K232400", "K190664", "K170750", "K180308", "K032456" ], "registration_number": [ "3005136058", "3009077524", "3009302839", "3003873069", "9617978", "3007791541", "3022719374", "3004977335", "3044735888", "2030598", "3013410552", "3002808157", "3022745617", "3008156050", "3011716550", "3004555507", "1651102", "2916710", "3004561814", "1038814", "3014425747", "3009529630", "3016686005", "3003418325", "3015777306", "2939248", "2183553", "3003094912", "3014873236", "3018004899", "3000126629", "3033527281", "3009090417", "3006894636", "3025765259", "3019543601", "3007037519", "9611894", "3019834893", "3006579682", "3010034862", "3004363352", "3042177665", "3004580128", "8043933", "3007774465", "3004608878", "3016602874", "3003586672", "3012039133", "3030564015", "3010123525", "3015232217", "3023344262", "2434141", "3003768277", "3004526608", "3003793371" ], "fei_number": [ "3008581796", "3005136058", "3009077524", "3009302839", "3003873069", "3002807741", "3007791541", "3022719374", "3004977335", "3044735888", "3013410552", "3002808157", "3022745617", "3008156050", "3011716550", "3004555507", "2916710", "3002619595", "3004561814", "1038814", "3014425747", "3002807880", "3009529630", "3016686005", "1000518731", "3003418325", "3015777306", "2939248", "2183553", "3003094912", "3014873236", "3018004899", "3000126629", "3033527281", "3009090417", "3006894636", "3025765259", "3019543601", "3007037519", "3019834893", "3006579682", "3010034862", "3004363352", "3042177665", "3004580128", "3007774465", "3004608878", "3016602874", "3003586672", "3002802883", "3012039133", "3030564015", "3010123525", "3015232217", "3023344262", "2434141", "3004526608", "3003793371" ], "device_name": "System, Planning, Radiation Therapy Treatment", "medical_specialty_description": "Radiology", "regulation_number": "892.5050", "device_class": "2" } } ] }