{ "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": "192633", "product_res_number": "Z-0850-2022", "event_date_initiated": "2022-02-11", "event_date_created": "2022-03-31", "recall_status": "Open, Classified", "res_event_number": "89822", "product_code": "MUJ", "k_numbers": [ "K211867" ], "product_description": "RayStation 4-11B, and RayPlan 1, 2, 7-11B including some service packs:\nRayStation 4.0 (4.0.0.14) to \nRayStation 5 Service Pack 2 (5.0.2.35), \nRayStation 5 Service Pack 3 (5.0.3.17), \nRayStation 6/RayPlan 2 (6.0.0.24), \nRayStation 6/RayPlan 2 Service Pack 1 (6.1.1.2), \nRayStation 6/RayPlan 2 Service Pack 2 (6.2.0.7), \nRayStation 6/RayPlan 2 Service Pack 3 (6.3.0.6), \nRayStation/RayPlan 7 (7.0.0.19), \nRayStation/RayPlan 8A (8.0.0.61), \nRayStation/RayPlan 8A Service Pack 1 (8.0.1.10) \n\nSoftware versions: 4.0.0.14, 4.0.3.4, 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, 10.1.1.54, 11.0.0.951, 11.0.1.29, 11.0.3.116 or 12.0.0.932", "code_info": "UDI # 07350002010020, \n07350002010013,\n07350002010082,\n07350002010075,\n07350002010242,\n07350002010068,\n07350002010112,\n07350002010136,\n07350002010129,\n07350002010204,\n07350002010235,\n07350002010174,\n07350002010266,\n07350002010297,\n07350002010303,\n07350002010365,\n07350002010310,\n07350002010471,\n07350002010389,\n07350002010433,\n07350002010440,\n07350002010426", "firm_fei_number": "3010034862", "recalling_firm": "RaySearch America Inc", "address_1": "350 5th Ave Ste 5000 350 the empire state building 5th ave", "address_2": "Ste 5000", "city": "New York", "state": "NY", "postal_code": "10118-0110", "reason_for_recall": "Incorrect source to skin or surface distance (SSD) calculation may result in dose error when using RayStation system.", "root_cause_description": "Under Investigation by firm", "action": "A field safety notice dated February 07, 2022 was issued via email on February 11, 2022 which includes work around instructions to make sure that the SSD value is correct. Identify affected product via software version number(s). Notify all users and acknowledge receipt of the notice. For more information contact quality@raysearchlabs.com.", "product_quantity": "653 (US 149, OUS 504)", "distribution_pattern": "US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CT, DC, DE, FL, GA, HI, IA, ID, IL, KS, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, 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", "K260750", "K990475", "K031088", "K071760", "K111311", "K220141", "K013535", "K102915", "K201350", "K062032", "K022411", "K082221", "K080929", "K002237", "K133331", "K991815", "K002132", "K090182", "K092928", "K172163", 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