{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "192469", "product_res_number": "Z-0849-2022", "event_date_initiated": "2021-09-22", "event_date_created": "2022-03-31", "recall_status": "Open, Classified", "res_event_number": "89800", "product_code": "MUJ", "k_numbers": [ "K211867" ], "product_description": "RayStation/RayPlan versions 4 - 11A, including service packs.\nBuild Stations: 4.0.0.14, 4.0.3.4, 4.3.0.14, 4.5.1.14, 4.7.2.5, 4.7.3.13, 4.7.4.4, 4.7.5.4, 4.7.6.7, 4.9.0.42, 5.0.1.11, 5.0.2.35, 5.0.3.17, 6.0.0.24, 6.1.1.2, 6.2.0.7, 6.3.0.6, 7.0.0.19, 8.0.0.61, 8.0.1.10, 8.1.0.47, 8.1.1.8, 8.1.2.5, 9.0.0.113, 9.1.0.933, 9.2.0.483, 10.0.0.1154, 10.0.1.52, 10.1.0.613, 11.0.0.951 or 11.0.1.29", "code_info": "Product name (build number) UDI-DI\nRayStation 4.0 (4.0.0.14) to RayStation 5 Service Pack 2 (5.0.2.35) N/A\nRayStation 5 Service Pack 3 (5.0.3.17) 07350002010020\nRayStation 6/RayPlan 2 (6.0.0.24) 07350002010013\nRayStation 6/RayPlan 2 Service Pack 1 (6.1.1.2) 07350002010082\nRayStation 6/RayPlan 2 Service Pack 2 (6.2.0.7) 07350002010075\nRayStation 6/RayPlan 2 Service Pack 3 (6.3.0.6) 07350002010242\nRayStation/RayPlan 7 (7.0.0.19) 07350002010068\nRayStation/RayPlan 8A (8.0.0.61) 07350002010112\nRayStation/RayPlan 8A Service Pack 1 (8.0.1.10) 07350002010136\nRayStation/RayPlan 8B (8.1.0.47) 07350002010129\nRayStation/RayPlan 8B Service Pack 1 (8.1.1.8) 07350002010204\nRayStation/RayPlan 8B Service Pack 2 (8.1.2.5) 07350002010235\nRayStation/RayPlan 9A (9.0.0.113) 07350002010174\nRayStation/RayPlan 9B (9.1.0.933) 07350002010266\nRayStation/RayPlan 9B Service Pack 1 (9.2.0.483) 07350002010297\nRayStation/RayPlan 10A (10.0.0.1154) 07350002010303\nRayStation/RayPlan 10A Service Pack 1 (10.0.1.52) 07350002010365\nRayStation/RayPlan 10B (10.1.0.613) 07350002010310\nRayStation 11A (11.0.0.951) 07350002010389\nRayStation 11A Service Pack 1 (11.0.1.29) 07350002010433", "firm_fei_number": "3007774465", "recalling_firm": "RAYSEARCH LABORATORIES AB", "address_1": "Sveavagen 9 9 sveavagen", "city": "Stockholm", "country": "Sweden", "reason_for_recall": "An issue where the combined density in a dose grid voxel partially covered by the External ROI and also partially covered by an ROI of type Bolus, Support or Fixation may be unexpected.The density in the voxel can be both under- and overestimated", "root_cause_description": "Device Design", "action": "RaySearch issued Field Safety Notice, Medical Device Correction #84236 via E-mail on 22 September 2021. Letter states reason for recall, health risk and action to take:\n\" Use the automatic tool in RayStation/RayPlan to create the External ROI.\n\" When using a Support or Fixation ROI of tissue-like material (density around 1), extend this ROI a few millimeters inside the External ROI to cover the surface voxels of the patient.\n\" If the Support or Fixation ROI differs significantly from the adjacent body tissue, an extra help ROI with material override set to a suitable material, for example, Skin, can be created inside the External ROI. The help ROI must have a width of a few millimeters and extend along the part of the patient surface connected to the Support or Fixation ROI. The same workflow can be used for Bolus ROIs in combination with electron beams.\n\n\" If the bolus/support/fixation device is part of the CT data, an alternative solution is to include its\nstructure inside the External ROI. In this case the structure should not be defined as a Bolus,\nSupport or Fixation ROI, but as a normal ROI, by setting the ROI type to, for example Other .\nWhen included in the External ROI, the user can choose to use the CT densities or to apply a\nmaterial override to the structure. If this method is applied for a bolus, the user must make sure\nthat only the applicable beams pass through the structure.\n\" For protons and light ions, the user should consider using a higher density uncertainty than\nnormal in robust optimization for active scanning techniques and larger proximal and distal\nmargins for the target in passive techniques, when shooting through a Fixation or Support ROI.\n\" Educate planning staff and all users about this workaround.\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.\n\nThis issue will be resolved in the next version of", "product_quantity": "478 licenses US", "distribution_pattern": "US Nationwide.", "openfda": { "k_number": [ "K000922", "K022036", "K120551", "K252863", "K211034", "K041719", "K915691", "K232400", "K220582", "K202284", "K170750", "K253050", "K011246", "K080601", "K991237", "K063482", "K141283", "K223279", "K091492", "K110730", "K151666", "K062514", "K141900", "K083414", "K113102", "K090808", "K151369", "K082642", "K223724", "K022741", "K083264", "K260308", "K091179", "K093588", "K234068", "K181145", "K260750", "K990475", "K031088", "K071760", "K111311", "K220141", "K013535", "K102915", "K201350", "K062032", "K022411", "K082221", "K080929", "K002237", "K133331", "K991815", "K002132", "K090182", "K092928", "K172163", "K001295", "K212274", "K013661", "K994413", "K222803", "K131428", "K093391", "K173635", "K202789", "K180379", "K091145", "K171536", "K242463", "K183037", "K002240", "K170969", "K223233", "K050296", "K051497", "K180289", "K152393", "K141860", "K130617", "K021268", "K230557", "K052325", "K020971", "K041997", "K203469", "K180308", "K112776", "K250963", "K220783", "K253091", "K090893", "K200487", "K981678", "K982696", "K193109", "K012575", "K231825", "K242992", "K040688", "K984196", "K182888", "K191384", "K002312", "K001700", "K100092", "K131891", "K190178", "K080888", "K214081", "K211867", "K983343", "K160093", "K232799", "K142108", "K083502", "K031281", "K992762", "K112723", "K090972", "K211881", "K002147", "K061893", "K192554", "K993766", "K082005", "K121448", "K032209", "K213438", "K993675", "K032456", "K252304", "K103093", "K082606", "K161136", "K171885", "K151380", "K150547", "K143514", "K170355", "K252784", "K042861", "K010682", "K013112", "K041971", "K241318", "K240671", "K112060", "K132816", "K162370", "K042739", "K201444", "K002509", "K100552", "K062967", "K123357", "K250440", "K992434", "K211379", "K211511", "K242378", "K013644", "K201607", "K222728", "K101076", "K210645", "K102011", "K982821", "K083672", "K992864", "K173940", "K151233", "K100417", "K151560", "K133655", "K203766", "K101220", "K103246", "K233236", "K053584", "K010784", "K222312", "K992753", "K193640", "K031349", "K974770", "K190387", "K143269", "K250064", "K081281", "K140187", "K151435", "K032724", "K133247", "K132971", "K112446", "K984532", "K182665", "K253078", "K071938", "K252002", "K151469", "K022961", "K232479", "K151887", "K203681", "K051941", "K100056", "K193381", "K200569", "K993923", "K141248", "K260207", "K030821", "K243057", "K102216", "K242748", "K190664", "K982791", "K993895", "K170086", "K213787", "K193459", "K063230", "K241876", "K032345", "K040474", "K200608", "K020027", "K990071", "K240398", "K120387", "K152488", "K013673", "K041403", "K022307", "K123263", "K123152", "K071873", "K090531", "K092132", "K103515", "K211841", "K120363", "K091146", "K042269", "K192065", "K101119", "K242822", "K103146", "K061097", "K073020", "K153368", "K992303", "K252109", "K081112", "K012017", "K061440" ], "registration_number": [ "3007037519", "3025309924", "3004977335", "3010034862", "3018004899", "3003586672", "3013410552", "2183553", "2434141", "3011716550", "8043933", "2916710", "3022719374", "3015777306", "3003094912", "3003418325", "3000126629", "3008156050", "3009090417", "3006894636", "3014873236", "3019543601", "3003768277", "3019834893", "3004363352", "3025765259", "3044735888", "3002808157", "9617978", "3014425747", "3004580128", "3015232217", "3007774465", "3003793371", "3009077524", "2030598", "3009529630", "9611894", "3005136058", "3030564015", "1651102", "3004561814", "1038814", "3010123525", "3006579682", "3004555507", "3022745617", "3033527281", "2939248", "3009302839", "3003873069", "3004526608", "3016686005", "3042177665", "3012039133", "3016602874", "3023344262", "3007791541", "3004608878" ], "fei_number": [ "3002619595", "3007037519", "3002807880", "3025309924", "3004977335", "3010034862", "3018004899", "3003586672", "3013410552", "2183553", "2434141", "3011716550", "2916710", "3002807741", "3022719374", "3015777306", "3003094912", "3003418325", "3000126629", "3008156050", "3009090417", "3006894636", "3014873236", "3019543601", "1000518731", "3019834893", "3004363352", "3025765259", "3002802883", "3044735888", "3002808157", "3014425747", "3004580128", "3015232217", "3007774465", "3003793371", "3009077524", "3005136058", "3009529630", "3030564015", "1038814", "3004561814", "3010123525", "3006579682", "3004555507", "3022745617", "3008581796", "3033527281", "2939248", "3009302839", "3003873069", "3004526608", "3016686005", "3042177665", "3012039133", "3016602874", "3023344262", "3007791541", "3004608878" ], "device_name": "System, Planning, Radiation Therapy Treatment", "medical_specialty_description": "Radiology", "regulation_number": "892.5050", "device_class": "2" } } ] }