{ "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": "149543", "product_res_number": "Z-0038-2017", "event_date_initiated": "2016-09-01", "event_date_created": "2016-10-04", "recall_status": "Terminated", "event_date_terminated": "2019-06-11", "res_event_number": "75173", "product_code": "MUJ", "k_numbers": [ "K160093" ], "product_description": "RayStation 2.5, 3.0, 3.5, 4.0, 4.5, 4.7, 5.0 and 4.3 (InverseArc 1.0) -- Radiation Therapy Treatment Planning System\nRayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs.", "code_info": "Build Numbers: 2.5.0.144, 2.5.1.89, 3.0.0.251, 3.5.0.16, 3.5.1.6, 4.0.0.14, 4.0.1.4, 4.0.2.9, 4.0.3.42, 4.3.0.14, 4.5.0.19, 4.5.1.14, 4.5.2.7, 4.7.0.15, 4.7.1.10, 4.7.2.5, 4.7.4.4, 4.7.5.4, 5.0.0.37, 5.0.1.11 or 5.0.2.35.", "firm_fei_number": "3007774465", "recalling_firm": "RAYSEARCH LABORATORIES AB", "address_1": "Sveavaegen 9 9 sveavaegen", "city": "Stockholm", "country": "Sweden", "reason_for_recall": "RaySearch became aware of the problem as it was discovered in cooperation with a customer experimenting with the dose calculation on a phantom. The correction concerns two issues found with the dose calculation when using a region of interest (ROI) of type Fixation or Support with material override within the patient outline (External ROI) in RayStation 2.5, 3.0, 3.5, 4.0, 4.5, 4.7, 5.0 and 4.3 (InverseArc 1.0).", "root_cause_description": "Under Investigation by firm", "action": "RaySearch sent a Field Safety Notice, on September 1, 2016, (RSL-D-61-301, dated 9/5/2016), was sent by e-mail to all affected customers. \nACTIONS TO BE TAKEN BY THE USER\nDo not use ROIs of type Fixation or Support within the patient outline. Always use other ROI types for\nmaterial override within the External ROI. A small overlap with the External ROI is acceptable if the Fixation\nor Support ROI is mainly outside the External ROI.\nPlease educate planning staff and all users about this workaround.\nInspect your product and identify all installed units with the above software version number, then confirm\nyou have read and understood this notice (contact information below).\nSOLUTION\nA correction of these issues will be available in the next version of RayStation, scheduled for market release\nin December 2016. In the meantime, this field safety notice is distributed to all customers. Until a corrected\nversion has been installed, all affected users must maintain awareness of this field safety notice.\nTRANSMISSION OF THIS FIELD SAFETY NOTICE\nThis notice needs to be passed on to all those who need to be aware within your organization. Please\nmaintain awareness of this notice as long as this version of RayStation is in use to ensure effectiveness of\nthe workaround.", "product_quantity": "USA: 522 units, OUS 846 units", "distribution_pattern": "Nationwide distribution", "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" } } ] }