{ "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": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "cfres_id": "214804", "product_res_number": "Z-2097-2025", "event_date_initiated": "2025-06-20", "event_date_posted": "2025-07-08", "recall_status": "Open, Classified", "res_event_number": "97193", "product_code": "KPS", "k_numbers": [ "K022960" ], "product_description": "Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye 4 Nuclear Medicine system", "code_info": "Serial Numbers:\n\nInfinia I\n16143\n16149\n16179\n16315\n16335\n16353\n16826\n17339\n17799\n18420\n18442\n18604\n18605\n18611\n18624\n18627\n18628\n18629\n18637\n18639\n18641\n18644\n18645\n18647\n18648\n18649\n18650\n18651\n18652\n18653\n18655\n18656\n18657\n193S08002;\n\nInfinia I Hawkeye 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II\n16045\n16094\n16115\n16135\n16170\n16190\n16191\n16194\n16196\n16198\n16206\n16207\n16208\n16209\n16211\n16212\n16213\n16214\n16218\n16220\n16221\n16223\n16224\n16227\n16228\n16229\n16234\n16235\n16239\n16244\n16246\n16250\n16259\n16262\n16263\n16271\n16279\n16285\n16296\n16303\n16304\n16305\n16310\n16312\n16313\n16318\n16319\n16322\n16323\n16324\n16326\n16334\n16336\n16355\n16356\n16365\n16370\n16371\n16372\n16376\n16382\n16404\n16408\n16411\n16412\n16413\n16415\n16418\n16419\n16421\n16425\n16426\n16428\n16434\n16437\n16442\n16446\n16455\n16456\n16457\n16460\n16465\n16466\n16469\n16470\n16474\n16475\n16478\n16483\n16489\n16491\n16497\n16499\n16500\n16504\n16509\n16513\n16525\n16526\n16528\n16531\n16533\n16538\n16539\n16541\n16542\n16553\n16557\n16559\n16560\n16564\n16566\n16576\n16579\n16583\n16585\n16587\n16592\n16608\n16611\n16614\n16621\n16626\n16627\n16628\n16632\n16634\n16635\n16636\n16639\n16640\n16643\n16645\n16646\n16648\n16649\n16656\n16657\n16658\n16659\n16660\n16661\n16662\n16663\n16664\n16665\n16667\n16668\n16670\n16672\n16673\n16677\n16680\n16683\n16686\n16692\n16694\n16695\n16696\n16699\n16705\n16706\n16710\n16712\n16715\n16716\n16719\n16720\n16725\n16732\n16733\n16734\n16736\n16738\n16739\n16743\n16746\n16748\n16750\n16751\n16758\n16760\n16761\n16766\n16767\n16768\n16770\n16772\n16773\n16775\n16776\n16779\n16783\n16786\n16788\n16789\n16790\n16792\n16793\n16794\n16800\n16802\n16803\n16804\n16806\n16812\n16814\n16816\n16817\n16819\n16823\n16828\n16830\n16837\n16839\n16841\n16848\n16851\n16853\n16854\n16858\n16859\n16860\n16861\n16863\n16864\n16866\n16870\n16877\n16882\n16896\n16900\n16902\n16904\n16908\n16912\n16916\n16918\n16920\n16923\n16929\n16935\n16937\n16939\n16940\n16941\n16943\n16960\n16963\n16964\n16965\n16969\n16970\n16971\n16972\n16973\n16976\n16984\n16988\n16991\n16993\n17001\n17003\n17006\n17007\n17008\n17009\n17012\n17014\n17015\n17016\n17017\n17026\n17027\n17031\n17036\n17040\n17043\n17045\n17054\n17059\n17064\n17066\n17069\n17073\n17074\n17075\n17076\n17078\n17080\n17081\n17093\n17096\n17102\n17111\n17115\n17117\n17119\n17123\n17128\n17129\n17132\n17133\n17134\n17141\n17142\n17144\n17146\n17150\n17153\n17155\n17159\n17160\n17162\n17167\n17168\n17170\n17175\n17176\n17177\n17182\n17183\n17184\n17186\n17188\n17189\n17192\n17196\n17201\n17202\n17203\n17206\n17211\n17212\n17216\n17218\n17221\n17223\n17224\n17228\n17229\n17230\n17235\n17239\n17240\n17242\n17246\n17253\n17256\n17257\n17261\n17263\n17266\n17270\n17271\n17273\n17274\n17275\n17279\n17281\n17283\n17292\n17294\n17296\n17302\n17303\n17304\n17305\n17307\n17311\n17313\n17314\n17315\n17320\n17321\n17324\n17327\n17329\n17332\n17334\n17335\n17342\n17355\n17356\n17357\n17359\n17361\n17364\n17365\n17366\n17367\n17368\n17371\n17375\n17378\n17380\n17386\n17393\n17394\n17397\n17401\n17402\n17403\n17411\n17413\n17418\n17419\n17420\n17421\n17424\n17426\n17427\n17428\n17431\n17432\n17433\n17434\n17436\n17438\n17441\n17443\n17444\n17446\n17448\n17451\n17454\n17456\n17465\n17468\n17471\n17472\n17483\n17487\n17489\n17498\n17501\n17504\n17505\n17512\n17516\n17518\n17519\n17521\n17523\n17524\n17525\n17527\n17538\n17548\n17551\n17552\n17553\n17554\n17555\n17556\n17557\n17558\n17560\n17562\n17563\n17564\n17565\n17584\n17591\n17592\n17593\n17604\n17609\n17610\n17612\n17614\n17617\n17618\n17621\n17628\n17630\n17632\n17640\n17642\n17652\n17653\n17657\n17660\n17667\n17671\n17672\n17673\n17675\n17676\n17683\n17684\n17687\n17688\n17693\n17694\n17698\n17708\n17712\n17713\n17715\n17726\n17730\n17735\n17739\n17743\n17744\n17746\n17748\n17752\n17753\n17760\n17761\n17762\n17763\n17765\n17766\n17768\n17769\n17771\n17772\n17775\n17777\n17780\n17781\n17782\n17784\n17785\n17787\n17789\n17790\n17791\n17794\n17798\n17802\n17803\n17806\n17808\n17811\n17812\n17815\n17816\n17818\n17823\n17826\n17829\n17831\n17832\n17834\n17836\n17838\n17840\n17842\n17843\n17845\n17846\n17849\n17851\n17854\n17855\n17856\n17857\n17859\n17860\n17861\n17862\n17863\n17864\n17866\n17868\n17871\n17872\n17874\n17875\n17876\n17877\n17878\n17879\n17883\n17886\n17887\n17891\n17892\n17893\n17894\n17895\n17897\n17898\n17899\n17900\n17901\n17902\n17908\n17909\n17910\n17911\n17912\n17913\n17914\n17919\n17924\n17925\n17929\n17936\n17938\n17939\n17941\n17944\n17945\n17947\n17948\n17951\n17952\n17957\n17958\n17962\n17964\n17965\n17968\n17969\n17970\n17971\n17972\n17975\n17980\n17981\n17982\n17984\n17988\n17991\n17992\n17993\n17996\n17997\n17998\n18002\n18006\n18012\n18015\n18025\n18027\n18029\n18030\n18031\n18033\n18036\n18046\n18048\n18051\n18052\n18054\n18059\n18063\n18064\n18065\n18066\n18067\n18070\n18076\n18078\n18083\n18088\n18089\n18091\n18092\n18095\n18097\n18101\n18103\n18104\n18106\n18109\n18110\n18114\n18115\n18117\n18119\n18120\n18125\n18128\n18130\n18136\n18137\n18138\n18142\n18144\n18145\n18146\n18148\n18150\n18151\n18155\n18157\n18160\n18163\n18164\n18165\n18167\n18173\n18174\n18176\n18177\n18178\n18179\n18188\n18191\n18192\n18194\n18197\n18201\n18203\n18206\n18207\n18209\n18211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II HAWKEYE 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"firm_fei_number": "3004571294", "recalling_firm": "GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING", "address_1": "4, Hayozma St 4 Hayozma St", "city": "Tirat Carmel", "country": "Israel", "additional_info_contact": "GE HealthCare Service\n800-4371171", "reason_for_recall": "Unintended radial detector motion may occur during patient setup or during patient scan if system does not have correct version of gantry software installed. Unintended detector motion may result in life-threatening injury.", "root_cause_description": "Software design", "action": "Firm notified customers via Urgent Medical Device Correction letter dated June 20, 2025.\n\nCustomers were instructed to check gantry software version. Instructions to do so are included in the letter. If system has the correct gantry software version, customers may continue to use their system--V.25BK for Infinia Running on Windows2000 (Win2K); C.15BK or C.1523 for Infinia on Windows XP; V.60BK on VG (all operating systems).\n\nIf the software version is not the correct version, customers should discontinue use of system and contact GE HealthCare Service or local Service Representative.\n\nGE HealthCare will correct systems at no cost to the customer. Correction will include a hardware update and, if necessary, a software update. GE HealthCare representatives will contact customers to arrange for the correction.\n\nIf you have any questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.", "product_quantity": "1822", "distribution_pattern": "Worldwide - US Nationwide distribution.", "openfda": { "k_number": [ "K981553", "K040141", "K031872", "K101768", "K962100", "K041218", "K083649", "K072567", "K900892", "K210880", "K942145", "K042903", "K862511", "K922427", "K202349", "K182484", "K170490", "K163394", "K081135", "K082244", "K131625", "K923151", "K922426", "K963730", "K071503", "K062393", "K152880", "K211846", "K172609", "K230600", "K101550", "K930428", "K210173", "K040370", "K123646", "K041182", "K041543", "K080575", "K894056", "K123599", "K003882", "K080124", "K921008", "K960948", "K033782", "K151486", "K110507", "K201807", "K173023", "K974256", "K002584", "K141652", "K922303", "K090553", "K221932", "K981027", "K951144", 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"medical_specialty_description": "Radiology", "regulation_number": "892.1200", "device_class": "2" } } ] }