{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "167279", "product_res_number": "Z-0005-2019", "event_date_initiated": "2018-08-20", "event_date_created": "2018-10-01", "recall_status": "Terminated", "event_date_terminated": "2020-08-28", "res_event_number": "81010", "product_code": "IYE", "k_numbers": [ "K150706" ], "product_description": "VitalBeam Radiotherapy Delivery System Version 2.5\n\nProduct Usage: The VitalBeam delivery systems are intended to provide precision radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.", "code_info": "VitalBeam Version 2.5MR1 Systems (software 02.05.13.05/02.05.13.07): H192482\tVITAL BEAM - 321274492 H192521\tVITAL BEAM H192743\tVITAL BEAM H192816\tVITAL BEAM  Varian Product Code family H19, which includes TrueBeam, TrueBeam STx, VitalBeam and EDGE.", "firm_fei_number": "3006583922", "recalling_firm": "Varian Medical Systems", "address_1": "3100 Hansen Way", "city": "Palo Alto", "state": "CA", "postal_code": "94304-1030", "reason_for_recall": "Reports have been received of an anomaly that can result in a treatment without intended gating (respiratory tracking/monitoring). This issue occurs when a patient planned with gating is treated on more than one system.", "root_cause_description": "Software design", "action": "On 08/20/2018 the firm sent an URGENT MEDICAL DEVICE CORRECTION FIELD SAFETY NOTICE to customer via courier service (US and Canada via FedEx on 8/23/2018, and Rest of World via third party courier on 8/24/2018) informing them the firm had received reports of an anomaly that can result in a treatment without intended gating, and that this issue occurs when a patient planned with gating is treated on more than one system. Customers were advised, for treatment plans with intended gating, the firm recommends users monitor and pay attention to the system status message. When a patient with a gated treatment plan is moved to a second system, users must verify that intending gating was not overridden. If gating is overridden, users should reselect it from the Tools menu. The customer were informed that they will be contacted by a Customer Service Representative to schedule upgrade to the correction when available and if they have any questions regarding selecting gating from the Tools menu to contact customer support.\n\nHelp Desk Contact Information:\nPhone: +1.888.827.4265\nEmail: support @varian.com\n\nIn addition, the URGENT MEDICAL DEVICE CORRECTION FIELD SAFETY NOTICE, informs the customers to:\n1) Please retain a copy of this document along with your most current product labeling.\n2) Advise the appropriate personnel working in your radiotherapy department of the content of this letter.\n3) For future reference, this document will be posted to the Varian Medical Systems customer support website: http://www.MyVarian.com.\nand In order to satisfy regulatory requirements, we request that you complete the attached Recall Return Response form provided. Kindly return the completed form to returnresponse@varian.com.", "product_quantity": "4", "distribution_pattern": "Worldwide Distribution - US nationwide in the states of AL, AR, AZ, CA, CO, FL, Guan, IL IN, KS, KY, LA, MA, MD, MI, MO, NH, NJ, NY, OH, OK, PA, Puerto Rico, TN, TX, VA, WI and the countries of :\nAlgeria, Australia, Azerbaijan, Belgium, Brazil, Bulgaria, Canada, China, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, India, Ireland, Israel, Italy, Japan, Kazakhstan, Lebanon, Morocco, Nepal, The Netherlands, New Zealand, Norway, Panama, Poland, Reunion Russia, Saudi Arabia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey and United Kingdom", "openfda": { "k_number": [ "K143560", "K952729", "K802808", "K130678", "K141855", "K951581", "K895500", "K033343", "K111862", "K131862", "K991336", "K970464", "K913174", "K192968", "K200940", "K101503", "K152761", "K160057", "K232113", "K940660", "K924632", "K012227", "K182076", 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Medical", "medical_specialty_description": "Radiology", "regulation_number": "892.5050", "device_class": "2" } } ] }