{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "196195", "product_res_number": "Z-0267-2023", "event_date_initiated": "2022-09-22", "event_date_posted": "2022-11-18", "recall_status": "Open, Classified", "res_event_number": "90916", "product_code": "CBK", "k_numbers": [ "K201658" ], "product_description": "Hamilton-C6", "code_info": "Model Number: 160021\nUDI-DI Code: 07630002808590\nAll Serial Numbers\nU.S. Serial Numbers\n6093\n6159\n6274\n6276\n6309\n6320\n6327\n6464\n6512\n6545\n6674\n6789\n7136\n7173\n7191\n7273\n7279\n7422\n7432\n7569\n7572\n7587\n7644\n7676\n7782\n7783\n7784\n7786\n7788\n7789\n7790\n7792\n7793\n7794\n7795\n7796\n7797\n7798\n7799\n7801\n7806\n7807\n7812\n7813\n7837\n7901\n7923\n7969\n8182\n8343\n8394\n8395\n8399\n8420\n8421\n8422\n8423\n8424\n8497\n8519\n8593\n8661\n8668\n8670\n8673\n8675\n8676\n8678\n8707\n8709\n8712\n9028\n9029\n9032\n9033\n9042\n9043\n9044\n9046\n14784\n4833\n5663\n5679\n5681\n5939\n6075\n6149\n6157\n6212\n6219\n6231\n6280\n6349\n6350\n6416\n6480\n6505\n6516\n6537\n6562\n6566\n6579\n6641\n6658\n6671\n6723\n6774\n6790\n6829\n6858\n6868\n6871\n6896\n6907\n6925\n6932\n6937\n6944\n6952\n6953\n6965\n6995\n7004\n7033\n7066\n7113\n7115\n7117\n7122\n7130\n7138\n7150\n7156\n7165\n7174\n7177\n7196\n7201\n7252\n7265\n7307\n7349\n7358\n7382\n7410\n7420\n7581\n7586\n7608\n7614\n7656\n7666\n7695\n7719\n7740\n7754\n7772\n7777\n7787\n7802\n7808\n7809\n7819\n7821\n7822\n7826\n7827\n7831\n7836\n7845\n7861\n7884\n7887\n7888\n7893\n7894\n7898\n7938\n7966\n7980\n7986\n7993\n7994\n8003\n8005\n8049\n8052\n8063\n8070\n8082\n8087\n8097\n8099\n8102\n8115\n8121\n8122\n8148\n8151\n8178\n8235\n8249\n8255\n8256\n8258\n8261\n8281\n8297\n8306\n8310\n8311\n8313\n8322\n8325\n8344\n8346\n8348\n8356\n8371\n8401\n8406\n8409\n8413\n8477\n8490\n8517\n8535\n8568\n8590\n8594\n8597\n8599\n8601\n8603\n8604\n8616\n8620\n8658\n8702\n8706\n8713\n8714\n8715\n8717\n8718\n8719\n8720\n8722\n8723\n8725\n8726\n8727\n8844\n8845\n8846\n8847\n8849\n8850\n8866\n9036\n9050\n9051\n9054\n9062\n9063\n9064\n9067\n9069\n9071\n9073\n9075\n9076\n9077\n9080\n9081\n9091\n9098\n9099\n9100\n9101\n9102\n9103\n9105\n9106\n9107\n9108\n9109\n9110\n9118\n9120\n9121\n9124\n9125\n9126\n9127\n9128\n9129\n9130\n9131\n9132\n9133\n9134\n9137\n9138\n9192\n9224\n9225\n9227\n9228\n9229\n9230\n9231\n9232\n9233\n9235\n9236\n9237\n9239\n9241\n9242\n9243\n9244\n9248\n9257\n9258\n9259\n9260\n9290\n9291\n9292\n9293\n9294\n9297\n9298\n9299\n9300\n9301\n9303\n9324\n9325\n9329\n9337\n9348\n9352\n9353\n9354\n9422\n9423\n9424\n9425\n9426\n9427\n9428\n9429\n9430\n9432\n9433\n9452\n9458\n9459\n9460\n9462\n9463\n9464\n9465\n9466\n9487\n9488\n9490\n9491\n9508\n9527\n9535\n9543\n9545\n9553\n9575\n9576\n9577\n9578\n9579\n9582\n9590", "firm_fei_number": "3014766741", "recalling_firm": "Hamilton Medical AG", "address_1": "Parc Industrial Vial 10 10 parc industrial vial", "city": "Domat/Ems", "country": "Switzerland", "additional_info_contact": "Kyle Hofer\n800-426-6331", "reason_for_recall": "Due to a malfunction related to the backlight on the ventilator screen. The screen goes black for approximately 2-3 seconds, but it brightens up again when the backlight switches on again.", "root_cause_description": "Under Investigation by firm", "action": "On 10/19/2022, Hamilton Medical, Inc. sent an \"URGENT - Medical Device Correction\" Letter via email to customers informing them the firm had received a complaint report associated with the backlight of the HAMILTON C-6 display failing. The failure is attributed to a reset of the HMI controller reset with causes the display to fail for 2-3 seconds. Hamilton Medical is notifying customer that this failure does not affect or interrupt the device's ventilation function.\n\nCustomers are instructed to:\n-Sign the enclosed sheet confirming that they have received and understood this Medical Device Correction. Also, continue to notify their local distribution partner of any cases of the aforementioned malfunction. No further action on their part is required. \n-Keep this information sheet with your HAMILTON-C6 Operator's Manual and prominently displayed as a constant reminder to the device users.\n\nFor questions, contact - \nHamilton Medical AG\nTechnical Support\nParc Industrial Vial 10\nCH-7013 Domat/Ems\nSwitzerland\nTel. +41 58 610 10 20\ne-mail: techsupport@hamilton-medical.com", "product_quantity": "8,229 total systems worldwide (U.S. 443 systems)", "distribution_pattern": "U.S. Nationwide distribution including in the states of CA, FL, GA, ID, IN, KS, KY, MA, MI, MO, NV, NM, NY, NC, OH, PA, Puerto Rico, SC, TX, VA, WA, WV, WI, and WY.", "openfda": { "k_number": [ "K081743", "K960168", "K022132", "K080181", "K822233", "K162738", "K023289", "K810893", "K173060", "K222644", "K241943", "K981072", "K170037", "K024344", "K760663", "K903010", "K900315", "K143035", "K983981", "K072885", "K982174", "K161450", "K180295", "K131774", "K111473", "K972203", "K870275", "K141943", "K915488", "K071526", 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