{ "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": "180369", "product_res_number": "Z-1598-2020", "event_date_initiated": "2020-03-04", "event_date_created": "2020-03-26", "recall_status": "Open, Classified", "res_event_number": "85255", "product_code": "MUJ", "k_numbers": [ "K190387" ], "product_description": "RayStation standalone software treatment planning system, Model Numbers 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 7.0, 8.0, 8.1, 9.0, 9.1 - Product Usage: RayStation is a software system for radiation therapy and medical oncology. Based on user input, RayStation proposes treatment plans. After a proposed treatment plan is reviewed and approved by authorized intended users, RayStation may also be used to administer treatments. The system functionality can be configured based on user needs.", "code_info": "Systems with software versions: 4.0.0.14 , 4.0.1.4 , 4.0.2.9 , 4.0.3.4 , 4.5.0.19 , 4.5.1.14 , 4.5.2.7 , 4.7.0.15 , 4.7.1.10 , 4.7.2.5 , 4.7.3.13 , 4.7.4.4 , 4.7.5.4 , 4.7.6.7 , 4.9.0.42 , 5.0.0.37 , 5.0.1.11 , 5.0.2.35 , 5.0.3.17 , 6.0.0.24 , 6.1.0.26 , 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 or 9.1.0.933", "firm_fei_number": "3007774465", "recalling_firm": "RAYSEARCH LABORATORIES AB", "address_1": "Sveavagen 9 9 sveavagen", "city": "Stockholm", "country": "Sweden", "reason_for_recall": "Due to physical limitations of the treatment machine, the maximum field opening for Siemens Virtual Wedge fields recommended by the LINAC vendor will be more restricted in the wedged direction than the maximum field opening without a wedge. Delivering a larger field opening with a virtual wedge will not result in a wedged field shape over the entire field. Instead, a high dose plateau region will be the result at the toe side of the field beyond the recommended field size.", "root_cause_description": "Under Investigation by firm", "action": "Field Safety Notice, Medical Device Correction #56089 was emailed to customers on 3/4/20. \n\nACTIONS TO BE TAKEN BY THE USER\n\" Do not use Siemens Virtual Wedge fields outside the Siemens recommended specification. If a\nfield outside the recommended specification with a virtual wedge is sent to the LINAC, the treatment\nmachine console (console software versions 8 and higher) will display a warning message, for\nexample Initial gap > 1 cm! Proceed (y/n)?, or The distance between the static jaw and the\nmoving jaw is greater than 1 cm. Do you want to continue? (y/n). If this happens, select n\nto prevent the treatment machine from delivering the field.\n\" In RayPhysics, use the wedge Field size limits parameters (Figure 3) to restrict the maximum\nallowed field size for a wedged field, see Setting wedge field size limits in RayPhysics on page6\nbelow for details.\n\" Verify through measurement at the LINAC that a wedged shape is delivered for the maximum field\nopening allowed by the Field size limits parameters for each wedge angle for Siemens Virtual\nWedge before clinical use.\nPlease educate planning staff and all users about this workaround.\nInspect your product and identify all installed units with the above software version number(s), then confirm\nthat you have read and understood this notice by replying to the notification email.\n\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 any version of RayStation/RayPlan affected by this issue is\nin use to ensure effectiveness of the workaround.\nThank you for your cooperation, and we apologize for any inconvenience.\n\nFor regulatory information, please contact quality@raysearchlabs.com", "product_quantity": "1389 licenses", "distribution_pattern": "US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, ID, IL, LA, MA, MD, ME, MI, MO, MS, MT, NC, NE, NJ, NY, OH, OK, OR, PA, RI, TN, TX, UT, VA, VT, WA, and WI.", "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", 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"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" } } ] }