{ "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": "2026-04-01", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "country": "United States", "city": "Palo Alto", "address_1": "3100 Hansen Way", "reason_for_recall": "Reports have been received of an anomaly that can result in a treatment without intended gating (respiratory tracking/monitoring). 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320868916 H192097 TRUEBEAM EDGE - 321103831 H192620 TRUEBEAM EDGE - SO#321382807 TrueBeam Edge version 2.0MR1 Systems (software 02.00.33.04): H192401 TRUEBEAM EDGE H192431 TRUEBEAM EDGE - SO#321276692 TrueBeam Edge version 2.5 Systems (software 02.05.13.03): H192447 TRUEBEAM EDGE TrueBeam Edge version 2.5MR1 Systems (software 02.05.13.05/02.05.13.07): H192124 TRUEBEAM EDGE - 321108891 H192301 TRUEBEAM EDGE H192435 TRUEBEAM EDGE¿ H192484 TRUEBEAM EDGE - SO# 321167229 H192578 TRUEBEAM EDGE H192691 TRUEBEAM EDGE - 321590884 H192709 TRUEBEAM EDGE¿ H192804 TRUEBEAM EDGE - 321549992 H192821 TRUEBEAM EDGE - 321544716 H192833 TRUEBEAM EDGE **************************************** TrueBeam Systems (software 02.00.29.03): H191204 TRUEBEAM H191266 TRUEBEAM - 320442198 H191396 TRUEBEAM H191397 TRUEBEAM H191423 TRUEBEAM H192127 TRUEBEAM - 321107941 TrueBeam STx (software 02.00.29.03): H191430 TRUEBEAM STX H191476 TRUEBEAM STX - SO#321792139 upg H191531 TRUEBEAM STX Varian Product Code family H19, which includes TrueBeam, TrueBeam STx, VitalBeam and EDGE.", "center_classification_date": "20181001", "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 : Algeria, 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", "state": "CA", "product_description": "TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.", "report_date": "20181010", "classification": "Class II", "openfda": {}, "recalling_firm": "Varian Medical Systems", "recall_number": "Z-0004-2019", "initial_firm_notification": "Letter", "product_type": "Devices", "event_id": "81010", "termination_date": "20200828", "more_code_info": "", "recall_initiation_date": "20180820", "postal_code": "94304-1030", "voluntary_mandated": "Voluntary: Firm initiated", "status": "Terminated" } ] }