{ "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": "182403", "product_res_number": "Z-2688-2020", "event_date_initiated": "2020-06-24", "event_date_created": "2020-07-22", "recall_status": "Terminated", "event_date_terminated": "2023-04-05", "res_event_number": "86000", "product_code": "MUJ", "k_numbers": [ "K192065" ], "product_description": "syngo.via RT Image Suite with software versions\nsyngo.via VB30 or VB40", "code_info": "syngo.via VB30 or VB40: All Lots Model #: 10496180", "firm_fei_number": "2240869", "recalling_firm": "Siemens Medical Solutions USA, Inc", "address_1": "40 Liberty Blvd", "city": "Malvern", "state": "PA", "postal_code": "19355", "additional_info_contact": "Rebecca Tudor\n610-219-4834", "reason_for_recall": "If the user modifies for any reason (e.g. reduction of artifacts) the original image orientation of a standard MR protocol to acquire images in a different orientation for further processing in Synthetic CT , the software does not recognize the adapted acquisition plane. This may result in images with wrong geometry. When this distortion remains unnoticed and the images are subsequently exported to a treatment planning system (TPS), an incorrect calculated radiation treatment plan cannot be excluded. The occurence of this issue is very unlikely and has never been reported so far.", "root_cause_description": "Software design", "action": "Siemens Healthcare Diagnostics sent a letter notification to customers dated June 23, 2020. The described issue will be solved with a service pack for software versions syngo.via VB30 and syngo.via VB40. Depending on your current software version, the service pack VB30A_HF08 will be installed with update SY039/20/S or the service pack VB40B_HF01 with update SY040/20/S as soon as it is available.", "product_quantity": "21 units", "distribution_pattern": "US Nationwide distribution including in the states of AZ, MA, WI, FL, PA. TX, MD, LA, TX, MN, MI, NY, SC, OH, GA, CA, IL, MO, CA, TX.", "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" } } ] }