{ "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": 1 } }, "results": [ { "cfres_id": "203529", "product_res_number": "Z-0206-2024", "event_date_initiated": "2023-09-12", "event_date_posted": "2023-11-01", "recall_status": "Open, Classified", "res_event_number": "93139", "product_code": "MUJ", "k_numbers": [ "K200487" ], "product_description": "RayCare 5B and 6A including service packs- An oncology information system used to support workflows and scheduling, as well as clinical information, planning and treatment management for oncology care\nProduct name (build number):\n(1)RayCare 5B SP1 (5.1.1.60246); \n(2)RayCare 5B SP3 (5.1.3.60023);\n(3) RayCare 6A (6.0.0.60553)", "code_info": "UDI-DI:\n(1)RayCare 5B SP1 (5.1.1.60246) 0735000201053220220316;\n(2)RayCare 5B SP3 (5.1.3.60023) 0735000201069320221027;\n(3) RayCare 6A (6.0.0.60553) 0735000201056320220617", "firm_fei_number": "3007774465", "recalling_firm": "RAYSEARCH LABORATORIES AB", "address_1": "Eugeniavagen 18c 18c eugeniavagen", "city": "Stockholm", "country": "Sweden", "reason_for_recall": "An issue was found in RayCare 5B, 6A, including service packs, where values will not be visible for documents in a read-only state when opened outside the Documents workspace when using document fields configured with single- or multi-selectable values.", "root_cause_description": "Under Investigation by firm", "action": "Raysearch issued Field Safety Notice, Medical Device Correction #121600 via email on 9/12/23. Letter states reason for recall, health risk and action to take:\nEducate staff and all users to open configurable documents from the Documents workspace to\navoid the issue.\n\" Review all configured documents and consider reconfiguration in a way that will not trigger the\nissue.\n\" Inspect your product and identify all installed units with the above software version number(s).\n\" Confirm you have read and understood this notice by replying to the notification email.\nSolution\nThis issue will be resolved in the next version of RayCare, scheduled for market release in December 2023\n(RayCare 2024A) (subject to market clearance in some markets). If customers wish to continue using versions of RayCare affected by this notice, all users must maintain awareness of this notice. Alternatively, customers can choose to upgrade to the new version once it becomes available for clinical use.\n\nFor regulatory information, please contact quality@raysearchlabs.com.", "product_quantity": "2 sytems", "distribution_pattern": "MD, TN", "openfda": { "k_number": [ "K071873", "K180308", "K001295", "K161136", "K990475", "K031349", "K233236", "K013112", "K041997", "K112060", "K242992", "K993675", "K160093", "K181145", "K121448", "K130617", "K173940", "K172163", "K250963", "K090531", "K012017", "K203766", "K013535", "K062032", "K082221", "K152393", "K220582", "K080601", "K123152", "K002237", "K091179", "K201350", "K170355", "K090182", "K200487", "K123357", "K241318", "K252784", "K011246", "K992753", "K041719", "K021268", "K243057", "K093391", "K082606", "K132816", "K010784", "K201607", "K022741", "K083672", "K002147", "K212274", "K151369", "K032209", "K091492", "K061097", "K102011", "K190178", "K042269", "K041971", "K083502", "K211034", "K100552", "K223233", "K092928", "K062514", "K151233", "K151469", "K210645", "K022036", "K222728", "K223279", "K002509", "K090893", "K982821", "K990071", "K170086", "K211379", "K214081", "K192554", "K142108", "K071938", "K193109", "K112776", "K013661", "K983343", "K232479", "K041403", "K101076", "K100092", "K111311", "K080888", "K071760", "K123263", "K222312", "K230557", "K993895", "K051497", "K101220", "K223724", "K193640", "K252109", "K101119", "K171885", "K020027", "K992864", "K915691", "K080929", "K180379", "K982791", "K141283", "K182888", "K102216", "K020971", "K994413", "K131891", "K143514", "K151666", "K220141", "K182665", "K202284", "K211841", "K250064", "K082005", "K042861", "K132971", "K151380", "K211881", "K103246", "K040688", "K030821", "K240671", "K153368", "K002312", "K234068", "K260207", "K253091", "K211867", "K131428", "K242822", "K002240", "K252002", "K133655", "K993923", "K031281", "K083264", "K191384", "K091146", "K110730", "K143269", "K992434", "K231825", "K220783", "K982696", "K993766", "K252304", "K090808", "K063230", "K141860", "K112723", "K240398", "K050296", "K200569", "K253050", "K000922", "K241876", "K103146", "K133247", "K242748", "K040474", "K120363", "K053584", "K081112", "K193381", "K082642", "K171536", "K093588", "K051941", "K232799", "K250440", "K031088", "K013644", "K151887", "K252863", "K013673", "K032456", "K170750", "K203469", "K061893", "K061440", "K052325", "K100417", "K253078", "K232400", "K032724", "K152488", "K091145", "K151435", "K183037", "K112446", "K192065", "K022307", "K103093", "K083414", "K012575", "K974770", "K103515", "K073020", "K141248", "K981678", "K170969", "K002132", "K151560", "K201444", "K211511", "K063482", "K141900", "K190387", "K140187", "K260750", "K102915", "K180289", "K203681", "K150547", "K242378", "K992762", "K001700", "K991237", "K100056", "K133331", "K984532", "K092132", "K202789", "K173635", "K162370", "K242463", "K992303", "K190664", "K022411", "K984196", "K010682", "K120551", "K090972", "K120387", "K213438", "K032345", "K081281", "K113102", "K200608", "K222803", "K022961", "K991815", "K260308", "K062967", "K042739", "K193459", "K213787" ], "registration_number": [ "3010123525", "3004608878", "3011716550", "3030564015", "9617978", "3003094912", "3010034862", "3013410552", "3007791541", "3009077524", "3022745617", "3033527281", "1038814", "3003586672", "2183553", "3004977335", "3002808157", "3019834893", "3006579682", "3016602874", "3009302839", "3006894636", "3004580128", "2030598", "3014425747", "3016686005", "3007037519", "3004555507", "3025765259", "3025309924", "3003873069", "3004526608", "3019543601", "3003768277", "3042177665", "1651102", "9611894", "3018004899", "3044735888", "3003793371", "8043933", "3012039133", "3008156050", "3023344262", "3007774465", "2434141", "3015232217", "3015777306", "3009090417", "3022719374", "3000126629", "3003418325", "3004363352", "2939248", "3004561814", "3009529630", "3014873236", "3005136058", "2916710" ], "fei_number": [ "3010123525", "3004608878", "3011716550", "3030564015", "3003094912", "3010034862", "3013410552", "3007791541", "3009077524", "3022745617", "3033527281", "1038814", "3003586672", "2183553", "3004977335", "3002808157", "3019834893", "3006579682", "3016602874", "3009302839", "3006894636", "1000518731", "3014425747", "3004580128", "3016686005", "3007037519", "3004555507", "3025765259", "3025309924", "3003873069", "3004526608", "3019543601", "3042177665", "3002807880", "3002807741", "3018004899", "3044735888", "3003793371", "3012039133", "3008581796", "3008156050", "3023344262", "3002802883", "3007774465", "2434141", "3015232217", "3015777306", "3009090417", "3022719374", "3000126629", "3002619595", "3003418325", "3004363352", "2939248", "3004561814", "3009529630", "3014873236", "3005136058", "2916710" ], "device_name": "System, Planning, Radiation Therapy Treatment", "medical_specialty_description": "Radiology", "regulation_number": "892.5050", "device_class": "2" } } ] }