{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "178438", "product_res_number": "Z-0736-2020", "event_date_initiated": "2019-11-18", "event_date_created": "2019-12-23", "recall_status": "Terminated", "event_date_terminated": "2020-11-10", "res_event_number": "84508", "product_code": "MUJ", "k_numbers": [ "K190387" ], "product_description": "RayStation stand-alone software treatment planning system, Model Numbers 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0 - Product Usage: RayStation 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. The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system.", "code_info": "Software Version Numbers: 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 , 4.9.0.42 , 5.0.0.37 ,  5.0.1.11 5.0.2.35 , 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 , or 9.0.0.113", "firm_fei_number": "3007774465", "recalling_firm": "RAYSEARCH LABORATORIES AB", "address_1": "Sveavagen 9 9 sveavagen", "city": "Stockholm", "country": "Sweden", "reason_for_recall": "Editing a static arc beam may unexpectedly set the MU of the beam to its initial default value of 200 MU. If the bug is triggered, the dose is invalidated and needs to be recalculated before the plan can be approved or exported.", "root_cause_description": "Software design", "action": "Field Safety Notice, Medical Device Correction notification letters dated 11/18/19 were sent to customers.\n\nACTIONS TO BE TAKEN BY THE USER\n\" Be aware that the MU of static arc beams may change unexpectedly when using the Edit beam dialog or when editing the beam aperture.\n\" Always review the final dose before approving a plan for treatment:\nWARNING!\nPlan review and approval. All treatment plan data shall be carefully reviewed and\napproved by a qualified person before it is used for radiotherapy treatment purposes.\nA plan (beam set) that is 'optimal' with respect to the optimization goals may still be inappropriate for clinical use. (508826, 508814)\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 that you have read and understood this notice by replying to the notification email.\nSOLUTION\nThis issue will be resolved in the next version of RayStation/RayPlan, scheduled for market release in December 2019 (subject to market clearance in some markets). If customers wish to continue using versions of RayStation/RayPlan affected by this notice, all users must maintain awareness of this notice.\nAlternatively, customers can choose to upgrade to the new version once it becomes available for clinical use.\nTRANSMISSION OF THIS NOTICE\nThis notice needs to be passed on to all those who need to be aware within your organization. Please maintain awareness of this notice as long as any version of RayStation/RayPlan affected by this issue is in use to ensure effectiveness of the workaround.", "product_quantity": "956 Devices/Licences", "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, NJ, NY, OH, OK, OR, PA, RI, TN, TX, UT, VA, VT, WA, and WI.", "openfda": { "k_number": [ "K132971", "K091179", "K982696", "K915691", "K211379", "K232400", "K171885", "K201444", "K982791", "K252304", "K012017", "K242992", "K211034", "K142108", "K041403", "K011246", "K041719", "K100056", "K160093", "K983343", "K180379", "K123263", "K051497", "K022036", "K991815", "K211841", "K260308", "K042269", "K100417", "K220783", "K082221", "K051941", "K100552", "K002312", "K201607", "K223279", "K151666", "K032724", "K210645", "K984532", "K150547", "K993675", "K133331", "K112723", "K081281", "K013112", "K211511", "K253078", "K994413", 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Treatment", "medical_specialty_description": "Radiology", "regulation_number": "892.5050", "device_class": "2" } } ] }