{ "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": 562 } }, "results": [ { "cfres_id": "167222", "product_res_number": "Z-0004-2019", "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": [ "K140528", "K143224" ], "product_description": "TrueBeam Radiotherapy Delivery System version 2.0 and 2.5\nEDGE Radiotherapy Delivery System version 2.0 and 2.5\n\nProduct 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.", "code_info": "TrueBeam version 2.0 Systems (software 02.00.33.02): H191007\tTRUEBEAM H191017\tTRUEBEAM H191024\tTRUEBEAM H191025\tTRUEBEAM - SO# 320239788 H191084\tTRUEBEAM H191100\tTRUEBEAM - SO# 320350217 H191131\tTRUEBEAM H191181\tTRUEBEAM - SO# 320394400 H191204\tTRUEBEAM H191207\tTRUEBEAM H191265\tTRUEBEAM H191266\tTRUEBEAM - 320442198 H191296\tTRUEBEAM H191326\tTRUEBEAM - 320649017 H191335\tTRUEBEAM - SO# 320534442 H191349\tTRUEBEAM - 320614871 H191369\tTRUEBEAM - SO# 320470280 H191385\tTRUEBEAM - 320612175 H191396\tTRUEBEAM H191397\tTRUEBEAM H191419\tTRUEBEAM H191423\tTRUEBEAM H191442\tTRUEBEAM H191457\tTRUEBEAM H191465\tTRUEBEAM - SO# 320740369 H191477\tTRUEBEAM H191491\tTRUEBEAM - SO# 320684489 H191537\tTRUEBEAM H191564\tTRUEBEAM - SO# 320816541 H191613\tTRUEBEAM H191616\tTRUEBEAM H191623\tTRUEBEAM H191627\tTRUEBEAM H191642\tTRUEBEAM H191647\tTRUEBEAM H191654\tTRUEBEAM H191670\tTRUEBEAM H191676\tTRUEBEAM - SO# 320886799 H191682\tTRUEBEAM - 320816854 H191685\tTRUEBEAM - SO# 320938575 H191699\tTRUEBEAM - SO#321147839 H191707\tTRUEBEAM H191714\tTRUEBEAM H191716\tTRUEBEAM - 320997927 H191718\tTRUEBEAM - 320649017 H191723\tTRUEBEAM H191724\tTRUEBEAM - SO# 320889109 H191726\tTRUEBEAM H191760\tTRUEBEAM H191772\tTRUEBEAM H191774\tTRUEBEAM H192006\tTRUEBEAM H192047\tTRUEBEAM (2.0 SLIM) - 320997331 H192059\tTRUEBEAM H192069\tTRUEBEAM H192070\tTRUEBEAM H192072\tTRUEBEAM H192073\tTRUEBEAM (2.0 SLIM) - 320936633 H192078\tTRUEBEAM H192093\tTRUEBEAM (2.0 SLIM) - 320997331 H192100\tTRUEBEAM H192102\tTRUEBEAM H192115\tTRUEBEAM - SO# 320997381 H192119\tTRUEBEAM - SO# 320997335 H192122\tTRUEBEAM H192125\tTRUEBEAM H192126\tTRUEBEAM - 321107941 H192127\tTRUEBEAM - 321107941 H192133\tTRUEBEAM H192141\tTRUEBEAM - SO# 321000817 H192168\tTRUEBEAM H192193\tTRUEBEAM - SO# 321119745 H192239\tTRUEBEAM - SO# 321068552 H192243\tTRUEBEAM - SO# 321000799 H192252\tTRUEBEAM - SO# 320997335 H192267\tTRUEBEAM - SO# 321156432 H192269\tTRUEBEAM - SO# 321156441 H192270\tTRUEBEAM - SO# 321156445 H192271\tTRUEBEAM - SO# 321156448 H192281\tTRUEBEAM H192289\tTRUEBEAM H192294\tTRUEBEAM H192321\tTRUEBEAM - SO# 320997325 H192391\tTRUEBEAM H191204\tTRUEBEAM H191266\tTRUEBEAM - 320442198 H191396\tTRUEBEAM H191397\tTRUEBEAM H191423\tTRUEBEAM H192127\tTRUEBEAM - 321107941  TrueBeam version 2.0MR1 Systems (software 02.00.33.04): H191197\tTRUEBEAM H191253\tTRUEBEAM H191306\tTRUEBEAM - 320633051 H191639\tTRUEBEAM - 320887142 H191709\tTRUEBEAM H192065\tTRUEBEAM H192110\tTRUEBEAM H192136\tTRUEBEAM - SO# 320943436 H192189\tTRUEBEAM - SO# 320943426 H192283\tTRUEBEAM  TrueBeam version 2.5 Systems (software 02.05.13.03): H191047\tTRUEBEAM - SO# 320269463 H191082\tTRUEBEAM - SO# 320349613 H191120\tTRUEBEAM - SO# 320390413 H191139\tTRUEBEAM H191147\tTRUEBEAM H191149\tTRUEBEAM - SO# 320450624 H191163\tTRUEBEAM - SO# 320395997 H191176\tTRUEBEAM - SO# 320177035 H191241\tTRUEBEAM - SO# 320443663 H191264\tTRUEBEAM - 320471285 H191276\tTRUEBEAM H191292\tTRUEBEAM H191293\tTRUEBEAM H191301\tTRUEBEAM H191309\tTRUEBEAM H191311\tTRUEBEAM H191342\tTRUEBEAM - SO# 320634237 H191355\tTRUEBEAM H191371\tTRUEBEAM - SO# 320538065 H191372\tTRUEBEAM H191373\tTRUEBEAM - SO# 320443408 H191375\tTRUEBEAM - SO# 320393735 H191384\tTRUEBEAM H191434\tTRUEBEAM H191444\tTRUEBEAM H191451\tTRUEBEAM - SO# 320634237 H191466\tTRUEBEAM H191480\tTRUEBEAM H191494\tTRUEBEAM - SO# 320515943 H191506\tTRUEBEAM - SO# 320589021 H191523\tTRUEBEAM H191524\tTRUEBEAM H191539\tTRUEBEAM H191551\tTRUEBEAM H191556\tTRUEBEAM - SO# 320589009 H191565\tTRUEBEAM H191590\tTRUEBEAM - 320785566 H191599\tTRUEBEAM - SO# 320634826 H191630\tTRUEBEAM - SO# 320836168 H191657\tTRUEBEAM - SO# 320734678 H191697\tTRUEBEAM H191770\tTRUEBEAM - 320890147 H191771\tTRUEBEAM - 321166276 H192044\tTRUEBEAM H192152\tTRUEBEAM - SO# 320941465 H192177\tTRUEBEAM H192178\tTRUEBEAM H192257\tTRUEBEAM - 320942552 H192266\tTRUEBEAM - SO# 321111637 H192299\tTRUEBEAM - SO# 320889915 H192313\tTRUEBEAM H192315\tTRUEBEAM H192342\tTRUEBEAM H192360\tTRUEBEAM H192378\tTRUEBEAM H192386\tTRUEBEAM H192388\tTRUEBEAM H192411\tTRUEBEAM H192422\tTRUEBEAM H192451\tTRUEBEAM H192453\tTRUEBEAM - SO# 321202021 H192456\tTRUEBEAM H192458\tTRUEBEAM H192473\tTRUEBEAM  TrueBeam version 2.5MR1 Systems (software 02.05.13.05/02.05.13.07): H191059\tTRUEBEAM - SO# 320264430 H191075\tTRUEBEAM - SO# 320337040 H191095\tTRUEBEAM H191115\tTRUEBEAM - SO# 320396943 H191117\tTRUEBEAM H191166\tTRUEBEAM - SO# 320351677 H191194\tTRUEBEAM H191250\tTRUEBEAM H191285\tTRUEBEAM H191291\tTRUEBEAM H191320\tTRUEBEAM H191322\tTRUEBEAM H191332\tTRUEBEAM H191333\tTRUEBEAM H191356\tTRUEBEAM - SO# 320471682 H191417\tTRUEBEAM - SO# 320585415 H191446\tTRUEBEAM H191473\tTRUEBEAM H191508\tTRUEBEAM H191588\tTRUEBEAM H191591\tTRUEBEAM H191606\tTRUEBEAM H191610\tTRUEBEAM - SO# 320815300 H191619\tTRUEBEAM H191644\tTRUEBEAM - SO# 320889534 H191646\tTRUEBEAM H191649\tTRUEBEAM H191650\tTRUEBEAM H191652\tTRUEBEAM H191663\tTRUEBEAM - 320810805 H191669\tTRUEBEAM - 320852536 H191673\tTRUEBEAM - SO# 320836166 H191675\tTRUEBEAM - SO# 320386532 H191690\tTRUEBEAM H191711\tTRUEBEAM H191749\tTRUEBEAM H191751\tTRUEBEAM - 320890150 H191752\tTRUEBEAM H191753\tTRUEBEAM H191758\tTRUEBEAM H191759\tTRUEBEAM H191764\tTRUEBEAM H191765\tTRUEBEAM H191767\tTRUEBEAM H191768\tTRUEBEAM H191773\tTRUEBEAM H192076\tTRUEBEAM - 320993070 H192086\tTRUEBEAM H192087\tTRUEBEAM - 320763229 H192089\tTRUEBEAM H192098\tTRUEBEAM - 321062057 H192114\tTRUEBEAM H192131\tTRUEBEAM H192138\tTRUEBEAM H192144\tTRUEBEAM - SO# 321023744 H192146\tTRUEBEAM - 321108755 H192163\tTRUEBEAM - 320982563 H192166\tTRUEBEAM H192169\tTRUEBEAM H192194\tTRUEBEAM H192200\tTRUEBEAM H192201\tTRUEBEAM - SO# 320880995 H192202\tTRUEBEAM - SO# 320880995 H192225\tTRUEBEAM H192241\tTRUEBEAM - 321163414 H192244\tTRUEBEAM H192287\tTRUEBEAM H192310\tTRUEBEAM - SO# 321105475 H192323\tTRUEBEAM - SO# 321000772 H192324\tTRUEBEAM - SO# 321111621 H192325\tTRUEBEAM - SO# 321223566 H192327\tTRUEBEAM H192329\tTRUEBEAM - SO# 321223566 H192341\tTRUEBEAM - SO# 321223566 H192343\tTRUEBEAM H192348\tTRUEBEAM H192349\tTRUEBEAM H192351\tTRUEBEAM H192352\tTRUEBEAM - 320924066 H192358\tTRUEBEAM H192365\tTRUEBEAM H192375\tTRUEBEAM - 320630873 H192376\tTRUEBEAM H192377\tTRUEBEAM - 320942521 H192379\tTRUEBEAM H192381\tTRUEBEAM H192390\tTRUEBEAM - SO# 321268743 H192392\tTRUEBEAM H192405\tTRUEBEAM H192410\tTRUEBEAM H192417\tTRUEBEAM H192418\tTRUEBEAM H192438\tTRUEBEAM - SO# 321111674 H192439\tTRUEBEAM H192441\tTRUEBEAM - SO# 321221591 H192444\tTRUEBEAM H192457\tTRUEBEAM H192466\tTRUEBEAM H192474\tTRUEBEAM - SO# 321051592 H192483\tTRUEBEAM H192486\tTRUEBEAM H192496\tTRUEBEAM H192497\tTRUEBEAM H192499\tTRUEBEAM H192500\tTRUEBEAM H192506\tTRUEBEAM H192520\tTRUEBEAM - SO# 321165761 H192527\tTRUEBEAM H192532\tTRUEBEAM H192533\tTRUEBEAM H192537\tTRUEBEAM H192541\tTRUEBEAM - SO# 321209716 H192548\tTRUEBEAM H192550\tTRUEBEAM H192558\tTRUEBEAM H192560\tTRUEBEAM - SO# 321275781 H192565\tTRUEBEAM H192567\tTRUEBEAM H192580\tTRUEBEAM - SO# 321376439 H192583\tTRUEBEAM - SO# 321108427 H192590\tTRUEBEAM - 321380296 H192595\tTRUEBEAM H192597\tTRUEBEAM - SO# 321328946 H192605\tTRUEBEAM H192610\tTRUEBEAM - SO# 321275873 H192614\tTRUEBEAM H192616\tTRUEBEAM - SO# 321221611 H192630\tTRUEBEAM - SO# 321373712 H192631\tTRUEBEAM - SO# 321373712 H192632\tTRUEBEAM H192638\tTRUEBEAM - SO# 321164402 H192645\tTRUEBEAM - SO#321382335 H192648\tTRUEBEAM H192652\tTRUEBEAM H192654\tTRUEBEAM H192658\tTRUEBEAM H192668\tTRUEBEAM - 320890159 H192671\tTRUEBEAM - SO#320997325 H192675\tTRUEBEAM - SO# 321278187 H192679\tTRUEBEAM - 320889323 H192680\tTRUEBEAM H192681\tTRUEBEAM H192693\tTRUEBEAM H192701\tTRUEBEAM - 321330605 H192703\tTRUEBEAM H192710\tTRUEBEAM H192759\tTRUEBEAM - SO# 321222124 H192760\tTRUEBEAM - 321393817 H192768\tTRUEBEAM H192787\tTRUEBEAM H192794\tTRUEBEAM H192799\tTRUEBEAM  TrueBeam Stx version 2.0 Systems (software 02.00.33.03): H191133\tTRUEBEAM STX H191289\tTRUEBEAM STX H191338\tTRUEBEAM STX H191418\tTRUEBEAM STX H191426\tTRUEBEAM STX - 320715156 H191429\tTRUEBEAM STX H191458\tTRUEBEAM STX H191482\tTRUEBEAM STX H191594\tTRUEBEAM STX - SO# 321197174 (Ugd) H191656\tTRUEBEAM STX - SO# 320883795 H191708\tTRUEBEAM STX H191719\tTRUEBEAM STX H191725\tTRUEBEAM STX H191750\tTRUEBEAM STX H192018\tTRUEBEAM STX EDGE H192048\tTRUEBEAM STX H192055\tTRUEBEAM STX H192215\tTRUEBEAM STX H191430\tTRUEBEAM STX H191476\tTRUEBEAM STX - SO#321792139 upg H191531\tTRUEBEAM STX  TrueBeam STx version 2.0MR1 Systems (software 02.00.33.04): H191035\tTRUEBEAM STX H191738\tTRUEBEAM STX - SO# 320974437  TrueBeam STx version 2.5 Systems (software 02.05.13.03): H191028\tTRUEBEAM STX - SO# 320175149 H191033\tTRUEBEAM STX H191038\tTRUEBEAM STX - SO# 320303883 H191068\tTRUEBEAM STX - 320307189 H191158\tTRUEBEAM STX - 320488589 H191217\tTRUEBEAM STX H191315\tTRUEBEAM STX H192151\tTRUEBEAM STX - SO# 320943434  TrueBeam STx version 2.5MR1 Systems (software 02.05.13.05/02.05.13.07): H191153\tTRUEBEAM STX - SO# 320327517 H191183\tTRUEBEAM STX - SO# 320442922 H191196\tTRUEBEAM STX H191274\tTRUEBEAM STX H191318\tTRUEBEAM STX H191321\tTRUEBEAM STX H191387\tTRUEBEAM STX H191448\tTRUEBEAM STX H191450\tTRUEBEAM STX - SO# 320686322 H191525\tTRUEBEAM STX - SO# 320588995 H191597\tTRUEBEAM STX H191637\tTRUEBEAM STX H191684\tTRUEBEAM STX H191739\tTRUEBEAM STX H192021\tTRUEBEAM STX - SO# 320589101 H192234\tTRUEBEAM STX H192357\tTRUEBEAM STX H192407\tTRUEBEAM STX H192493\tTRUEBEAM STX H192494\tTRUEBEAM STX H192498\tTRUEBEAM STX 321109749 H192507\tTRUEBEAM STX 321331339 H192566\tTRUEBEAM STX 321199361 H192598\tTRUEBEAM STX - SO#321109587 H192667\tTRUEBEAM STX 321070912 H192749\tTRUEBEAM STX 321294620 H192782\tTRUEBEAM STX 320997611 H192785\tTRUEBEAM STX 320997614 H192801\tTRUEBEAM STX H192807\tTRUEBEAM STX 320997610  TrueBeam Edge version 2.0 Systems (software 02.00.22.02): H192005\tTRUEBEAM EDGE - 320868916 H192097\tTRUEBEAM EDGE - 321103831 H192620\tTRUEBEAM EDGE - SO#321382807  TrueBeam Edge version 2.0MR1 Systems (software 02.00.33.04): H192401\tTRUEBEAM EDGE H192431\tTRUEBEAM EDGE - SO#321276692  TrueBeam Edge version 2.5 Systems (software 02.05.13.03): H192447\tTRUEBEAM EDGE  TrueBeam Edge version 2.5MR1 Systems (software 02.05.13.05/02.05.13.07): H192124\tTRUEBEAM EDGE - 321108891 H192301\tTRUEBEAM EDGE H192435\tTRUEBEAM EDGE¿ H192484\tTRUEBEAM EDGE - SO# 321167229 H192578\tTRUEBEAM EDGE H192691\tTRUEBEAM EDGE - 321590884 H192709\tTRUEBEAM EDGE¿ H192804\tTRUEBEAM EDGE - 321549992 H192821\tTRUEBEAM EDGE - 321544716 H192833\tTRUEBEAM EDGE  **************************************** TrueBeam Systems (software 02.00.29.03): H191204\tTRUEBEAM H191266\tTRUEBEAM - 320442198 H191396\tTRUEBEAM H191397\tTRUEBEAM H191423\tTRUEBEAM H192127\tTRUEBEAM - 321107941  TrueBeam STx (software 02.00.29.03): H191430\tTRUEBEAM STX H191476\tTRUEBEAM STX - SO#321792139 upg H191531\tTRUEBEAM STX  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": "387", "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", "K121663", "K250696", "K933117", "K142294", "K932598", "K904364", "K101751", "K043409", "K122888", "K141572", "K974703", "K892845", "K142142", "K121328", "K972804", "K201276", "K192482", "K222762", "K990997", "K960510", "K982549", "K014081", "K935300", "K112210", "K072916", "K062611", "K953570", "K150265", "K203722", "K170307", "K972816", "K820310", "K100801", "K142268", "K891292", "K052212", "K230576", "K060737", "K254010", "K232923", "K082909", "K132935", "K964167", "K200907", "K942092", "K112778", "K894230", "K931927", "K211001", "K980826", "K020294", "K181032", "K191761", "K100096", "K030051", "K024284", "K182138", "K110971", "K112692", "K243301", "K837347", "K151180", "K942346", "K010062", "K080742", "K173848", "K991107", "K911973", "K161146", "K963258", "K211939", "K991133", "K935412", "K150706", "K171133", "K193207", "K220583", "K991523", "K062817", "K082775", "K191646", "K223159", "K894912", "K141230", "K202068", "K003285", "K192102", "K252919", "K960293", "K103193", "K142617", 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