{ "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": "106201", "product_res_number": "Z-0516-2012", "event_date_initiated": "2011-11-23", "event_date_posted": "2012-01-11", "recall_status": "Terminated", "event_date_terminated": "2014-08-06", "res_event_number": "60684", "product_code": "IYE", "k_numbers": [ "K091209" ], "product_description": "Portal Vision, R-Arm with 4D Integrated Treatment Console;\nVarian Medical Systems. Palo Alto, CA.\n\nThe Portal Vision device is used for verification of the treatment field and shielding block in relation to anatomical landmarks in radiotherapy treatment. Portal Vision will also allow for verification of the exit dose in radiotherapy treatment.", "code_info": "Model H80, H81; Serial numbers: H800017\tH800447\tH800692\tH801949\tH803815\tH803912\tH803999\tH804090\tH804178\tH804271\tH804348\tH804439\tH804523 H800031\tH800453\tH800693\tH801951\tH803816\tH803913\tH804000\tH804091\tH804179\tH804272\tH804349\tH804442\tH804524 H800037\tH800457\tH800696\tH801952\tH803818\tH803914\tH804002\tH804092\tH804188\tH804273\tH804350\tH804443\tH804525 H800054\tH800467\tH800703\tH801955\tH803822\tH803919\tH804003\tH804094\tH804191\tH804274\tH804351\tH804444\tH804526 H800060\tH800469\tH800708\tH801969\tH803825\tH803922\tH804004\tH804095\tH804192\tH804275\tH804352\tH804446\tH804527 H800064\tH800470\tH800710\tH801971\tH803826\tH803923\tH804006\tH804097\tH804193\tH804276\tH804354\tH804447\tH804528 H800065\tH800474\tH800713\tH801976\tH803827\tH803925\tH804007\tH804099\tH804194\tH804278\tH804355\tH804448\tH804529 H800073\tH800489\tH800714\tH801986\tH803828\tH803928\tH804008\tH804100\tH804198\tH804279\tH804356\tH804449\tH804530 H800077\tH800490\tH800800\tH801991\tH803829\tH803930\tH804009\tH804101\tH804199\tH804280\tH804358\tH804450\tH804531 H800079\tH800498\tH800801\tH801993\tH803830\tH803932\tH804010\tH804105\tH804200\tH804281\tH804362\tH804451\tH804534 H800085\tH800500\tH800802\tH801994\tH803834\tH803933\tH804012\tH804106\tH804202\tH804282\tH804364\tH804452\tH804535 H800091\tH800501\tH800812\tH801996\tH803835\tH803934\tH804013\tH804108\tH804203\tH804284\tH804365\tH804454\tH804536 H800095\tH800503\tH800819\tH801997\tH803836\tH803935\tH804014\tH804111\tH804205\tH804287\tH804367\tH804455\tH804537 H800096\tH800505\tH800827\tH802000\tH803838\tH803937\tH804015\tH804112\tH804207\tH804288\tH804368\tH804456\tH804540 H800100\tH800521\tH800844\tH802011\tH803840\tH803938\tH804017\tH804113\tH804208\tH804289\tH804370\tH804458\tH804541 H800103\tH800522\tH800859\tH802017\tH803841\tH803940\tH804018\tH804114\tH804209\tH804291\tH804371\tH804459\tH804542 H800109\tH800527\tH800860\tH802019\tH803845\tH803941\tH804021\tH804115\tH804212\tH804294\tH804372\tH804461\tH804543 H800133\tH800528\tH800868\tH802022\tH803847\tH803942\tH804023\tH804116\tH804213\tH804295\tH804373\tH804464\tH804544 H800138\tH800532\tH800885\tH802026\tH803848\tH803945\tH804025\tH804118\tH804215\tH804296\tH804374\tH804465\tH804545 H800141\tH800537\tH800887\tH802030\tH803849\tH803948\tH804027\tH804119\tH804216\tH804298\tH804375\tH804466\tH804547 H800143\tH800538\tH800888\tH802032\tH803852\tH803949\tH804028\tH804120\tH804217\tH804299\tH804376\tH804468\tH804548 H800147\tH800541\tH800913\tH802033\tH803853\tH803951\tH804029\tH804121\tH804218\tH804300\tH804377\tH804471\tH804549 H800181\tH800542\tH800919\tH802034\tH803855\tH803954\tH804030\tH804122\tH804220\tH804302\tH804380\tH804473\tH804551 H800194\tH800545\tH800920\tH802035\tH803857\tH803955\tH804033\tH804123\tH804221\tH804305\tH804382\tH804474\tH804552 H800195\tH800555\tH800923\tH802036\tH803859\tH803958\tH804034\tH804124\tH804222\tH804308\tH804383\tH804476\tH804554 H800198\tH800566\tH800925\tH802038\tH803860\tH803959\tH804036\tH804125\tH804227\tH804309\tH804384\tH804477\tH804555 H800202\tH800567\tH800929\tH802057\tH803863\tH803960\tH804037\tH804128\tH804228\tH804310\tH804386\tH804479\tH804556 H800219\tH800574\tH800947\tH802058\tH803865\tH803963\tH804038\tH804129\tH804229\tH804311\tH804387\tH804482\tH804557 H800220\tH800575\tH801325\tH802061\tH803866\tH803964\tH804039\tH804132\tH804230\tH804312\tH804388\tH804483\tH804558 H800227\tH800580\tH801336\tH802062\tH803869\tH803965\tH804044\tH804135\tH804232\tH804314\tH804390\tH804484\tH804560 H800231\tH800585\tH801460\tH802069\tH803870\tH803966\tH804045\tH804136\tH804233\tH804315\tH804392\tH804485\tH804561 H800238\tH800586\tH801805\tH802070\tH803871\tH803967\tH804047\tH804137\tH804234\tH804316\tH804393\tH804487\tH804563 H800241\tH800598\tH801806\tH802072\tH803872\tH803968\tH804049\tH804138\tH804235\tH804317\tH804394\tH804488\tH804565 H800242\tH800600\tH801807\tH802073\tH803873\tH803969\tH804050\tH804140\tH804238\tH804319\tH804395\tH804489\tH804566 H800252\tH800602\tH801813\tH802079\tH803875\tH803970\tH804051\tH804141\tH804239\tH804320\tH804396\tH804491\tH804567 H800257\tH800614\tH801819\tH802086\tH803876\tH803971\tH804052\tH804142\tH804240\tH804321\tH804402\tH804492\tH804568 H800260\tH800616\tH801824\tH802087\tH803879\tH803973\tH804053\tH804143\tH804241\tH804322\tH804403\tH804493\tH804569 H800265\tH800617\tH801845\tH802092\tH803880\tH803974\tH804054\tH804144\tH804242\tH804323\tH804407\tH804494\tH804570 H800271\tH800618\tH801849\tH802094\tH803883\tH803975\tH804055\tH804146\tH804243\tH804324\tH804408\tH804495\tH804572 H800274\tH800625\tH801851\tH802096\tH803884\tH803977\tH804056\tH804147\tH804244\tH804325\tH804414\tH804497\tH804573 H800278\tH800626\tH801856\tH802097\tH803885\tH803978\tH804059\tH804148\tH804245\tH804326\tH804415\tH804500\tH804574 H800296\tH800632\tH801863\tH802100\tH803886\tH803979\tH804060\tH804149\tH804246\tH804327\tH804416\tH804501\tH804575 H800298\tH800634\tH801869\tH802101\tH803887\tH803981\tH804063\tH804150\tH804247\tH804329\tH804417\tH804502\tH804576 H800315\tH800637\tH801874\tH802105\tH803889\tH803982\tH804064\tH804151\tH804251\tH804330\tH804418\tH804503\tH804577 H800327\tH800638\tH801889\tH802107\tH803890\tH803983\tH804066\tH804156\tH804253\tH804331\tH804419\tH804505\tH804580 H800333\tH800641\tH801912\tH802110\tH803893\tH803984\tH804068\tH804159\tH804254\tH804332\tH804420\tH804508\tH804581 H800335\tH800643\tH801915\tH802111\tH803894\tH803985\tH804070\tH804160\tH804255\tH804333\tH804422\tH804510\tH804584 H800339\tH800646\tH801916\tH802112\tH803896\tH803986\tH804071\tH804161\tH804256\tH804334\tH804424\tH804511\tH804586 H800343\tH800648\tH801917\tH802116\tH803897\tH803987\tH804072\tH804162\tH804257\tH804335\tH804425\tH804512\tH804588 H800419\tH800654\tH801926\tH802118\tH803898\tH803988\tH804073\tH804163\tH804259\tH804338\tH804426\tH804513\tH804589 H800421\tH800655\tH801934\tH802133\tH803900\tH803989\tH804074\tH804165\tH804261\tH804339\tH804427\tH804515\tH804591 H800423\tH800660\tH801935\tH802283\tH803901\tH803990\tH804080\tH804166\tH804262\tH804340\tH804428\tH804516\tH804592 H800425\tH800662\tH801938\tH802402\tH803904\tH803991\tH804081\tH804167\tH804264\tH804341\tH804429\tH804517\tH804599 H800429\tH800665\tH801940\tH802925\tH803905\tH803993\tH804083\tH804168\tH804265\tH804342\tH804430\tH804518\tH804600 H800434\tH800670\tH801942\tH803043\tH803907\tH803994\tH804084\tH804172\tH804266\tH804343\tH804431\tH804519\tH804601 H800435\tH800679\tH801943\tH803382\tH803908\tH803995\tH804085\tH804175\tH804267\tH804344\tH804432\tH804520\tH804602 H800438\tH800689\tH801944\tH803608\tH803910\tH803997\tH804087\tH804176\tH804268\tH804346\tH804434\tH804521\tH804606 H800444\tH800690\tH801945\tH803806\tH803911\tH803998\tH804089\tH804177\tH804270\tH804347\tH804438\tH804522\tH804607", "firm_fei_number": "2916710", "recalling_firm": "Varian Medical Systems, Inc. Oncology Systems", "address_1": "911 Hansen Way", "city": "Palo Alto", "state": "CA", "postal_code": "94304-1028", "additional_info_contact": "Peter J. Coronado\n650-424-5731", "reason_for_recall": "An anomaly was discovered when using the 4DITC in combination with an R-Arm to acquire double exposure MV images.", "root_cause_description": "Software design", "action": "The firm, Varian Medical Systems, sent an \"URGENT MEDICAL DEVICE CORRECTION/URGENT FIELD SAFETY NOTICE\" dated December 1, 2011 to all affected sites via Certified mail, return receipt. Canadian accounts were sent by Fed Ex and internationally to Varian International Customer Support Managers for translation and notification of customers. The notice described the product, problem and actions to be taken. The customers were instructed to always acquire both the treatment port and the open port images BEFORE displaying the digital graticule, when using a standard double exposure template; and to advise the appropriate personnel working in their radiotherapy department of the content of this letter.\n\nSpecial instructions for customers outside the USA and Canada: these customers were instructed to complete and return the attached Proof of Notification or Receipt Verification Card to Varian Medical Systems, once they have read this document.\n \nVarian is developing a correction for this issue and a Customer Service rep will contact the customers when the correction is available to schedule its installation on their systems.\n\nIf you have any questions, contact USA and Canada at 1-888-827-4265; Europe: +41 41 749 8844; Email: North America: support-americas@varian.com; Australia/New Zealand: support-anz@varian.com; Europe: support-emea@varian.com; South East Asia: seasia.apps.helpdesk@varian.com; China/Asia: China.apps.helpdesk@varian.com; Japan: Japan-Apps.Helpdesk@varian.com and Latin America: soporte.al@varian.com or Internet: Oncology systems customer site: www.myvarian.com and Varian Medical Systems public site: www.varian.com.", "product_quantity": "1486 devices", "distribution_pattern": "Worldwide distribution: USA (nationwide) and countries of: Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Belarus, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France,, Georgia, Germany,Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Kazakhstan, Lativia, Macedonia, Malaysia, Martinique, Mexico, Montenegro, Morocco, Nepal, Netherlands, New Zealand, Norway, Oman, Panama, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom and Venezuela.", "openfda": { "k_number": [ "K972804", "K102671", "K930182", "K962080", "K152321", "K130678", "K052920", "K202747", "K020320", "K926008", "K943464", "K090044", "K932598", "K913612", "K223229", "K924495", "K051932", "K960510", "K210894", "K031634", "K223839", "K020294", "K963451", "K092845", "K173926", "K970586", "K951808", "K162862", "K922276", "K961170", "K003330", "K033343", "K122888", "K112286", "K970137", "K941118", "K182138", "K935411", "K140823", "K950866", "K250392", "K220539", "K871214", "K933614", "K181218", "K982463", "K253962", "K973889", "K960834", "K873398", "K100264", "K092041", "K071531", "K991319", "K981597", "K900434", "K032762", "K120233", "K970291", "K926321", "K102237", "K991133", "K142617", "K160209", "K142431", "K942092", "K832216", "K142294", "K200652", "K203387", "K123371", "K152867", "K070920", "K063839", "K925714", "K121663", "K200940", "K904364", "K160405", "K961484", "K153014", "K232031", 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