{
  "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": "2026-10-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "144608",
      "product_res_number": "Z-1562-2016",
      "event_date_initiated": "2016-03-15",
      "event_date_created": "2016-04-22",
      "recall_status": "Terminated",
      "event_date_terminated": "2016-11-07",
      "res_event_number": "73617",
      "product_code": "BSZ",
      "k_numbers": [
        "K110213",
        "K132530"
      ],
      "product_description": "GE Healthcare, Aisys and Aisys CS2.\n\nIntended to provide general inhalation anesthesia and ventilator support to a wide range of patients (neonatal, pediatric, and adult).",
      "code_info": "Mfg Lot or Serial #\tUDI IDENTIFIER APWU00723\tnot applicable APWU00724\tnot applicable APWU01988\t010084068210229221APWU0198811150921 APWU01989\t010084068210229221APWU0198911150921 APWU01990\t010084068210229221APWU0199011150921 APWU01991\t010084068210229221APWU0199111150921 APWU01992\t010084068210229221APWU0199211150921 APWU01993\t010084068210229221APWU0199311150921 APWU01994\t010084068210229221APWU0199411150921 APWU01995\t010084068210229221APWU0199511150921 APWU01996\t010084068210229221APWU0199611150921 APWU01997\t010084068210229221APWU0199711150921 APWU00707\tnot applicable APWU00708\tnot applicable APWU00709\tnot applicable APWU00710\tnot applicable APWU00711\tnot applicable APWU02166\t010084068210229221APWU0216611151014 APWU02170\t010084068210229221APWU0217011151014 APWU02171\t010084068210229221APWU0217111151014 APWU02172\t010084068210229221APWU0217211151014 APWU00712\tnot applicable APWU00505\tnot applicable APWU00506\tnot applicable APWU00507\tnot 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applicable APWU00173\tnot applicable APWU00174\tnot applicable APWU00488\tnot applicable APWU00489\tnot applicable APWU00490\tnot applicable APWU00491\tnot applicable APWU00492\tnot applicable APWU00493\tnot applicable APWU00494\tnot applicable APWU00495\tnot applicable APWU00496\tnot applicable APWU00313\tnot applicable APWU00914\tnot applicable APWU00898\tnot applicable APWU00872\tnot applicable APWU00873\tnot applicable APWU00874\tnot applicable APWU00915\tnot applicable APWU00836\tnot applicable APWU00370\tnot applicable APWU00371\tnot applicable APWU00307\tnot applicable APWU00412\tnot applicable APWU00464\tnot applicable APWU00465\tnot applicable APWU00466\tnot applicable APWU00467\tnot applicable APWU00468\tnot applicable APWU00469\tnot applicable APWU00470\tnot applicable APWU00471\tnot applicable APWU00472\tnot applicable APWU00473\tnot applicable APWU02039\t010084068210229221APWU0203911150929 APWU00319\tnot applicable APWU00320\tnot applicable APWU00321\tnot applicable APWU00322\tnot applicable APWU00323\tnot applicable APWU00840\tnot applicable APWU00841\tnot applicable APWU00842\tnot applicable APWU00843\tnot applicable APWU00844\tnot applicable APWU00845\tnot applicable APWU00846\tnot applicable APWU00847\tnot applicable APWU00247\tnot applicable APWU00936\tnot applicable APWU00211\tnot applicable APWU00212\tnot applicable APWU00213\tnot applicable APWU00214\tnot applicable APWU01761\t010084068210229221APWU0176111150819 APWU01762\t010084068210229221APWU0176211150819 APWU01763\t010084068210229221APWU0176311150819 APWU01764\t010084068210229221APWU0176411150819 APWU01765\t010084068210229221APWU0176511150819 APWU01766\t010084068210229221APWU0176611150819 APWU00891\tnot applicable APWU00892\tnot applicable APWU00343\tnot applicable APWU00933\tnot applicable APWU00935\tnot applicable APWU01220\tnot applicable APWU01221\tnot applicable APWU01222\tnot applicable APWU01223\tnot applicable APWU01224\tnot applicable APWU01225\tnot applicable APWU01226\tnot applicable APWU01227\tnot applicable APWU01228\tnot applicable APWU01229\tnot applicable APWU01230\tnot applicable APWU01231\tnot applicable APWU01232\tnot applicable APWU01233\tnot applicable APWU01234\tnot applicable APWU01235\tnot applicable APWU01236\tnot applicable APWU01237\tnot applicable APWU01238\tnot applicable APWU01239\tnot applicable APWU01255\tnot applicable APWU01256\tnot applicable APWU01257\tnot applicable APWU01258\tnot applicable APWU01268\tnot applicable APWU01269\tnot applicable APWU01270\tnot applicable APWU01271\tnot applicable APWU01272\tnot applicable APWU01273\tnot applicable APWU01274\tnot applicable APWU01275\tnot applicable APWU01276\tnot applicable APWU01277\tnot applicable APWU01278\tnot applicable APWU01279\tnot applicable APWU01280\tnot applicable APWU01281\tnot applicable APWU01282\tnot applicable APWU01283\tnot applicable APWU01284\tnot applicable APWU01285\tnot applicable APWU01286\tnot applicable APWU01287\tnot applicable APWU01288\tnot applicable APWU01289\tnot applicable APWU01206\tnot applicable APWU01207\tnot applicable APWU01208\tnot applicable APWU01209\tnot applicable APWU01210\tnot applicable APWU01211\tnot applicable APWU01212\tnot applicable APWU01213\tnot applicable APWU01214\tnot applicable APWU01215\tnot applicable APWU01216\tnot applicable APWU01217\tnot applicable APWU01218\tnot applicable APWU01219\tnot applicable APWU01458\tnot applicable APWU01459\tnot applicable APWU01460\tnot applicable APWU00931\tnot applicable APWU00932\tnot applicable APWU00391\tnot applicable APWU00450\tnot applicable APWU00615\tnot applicable APWU00616\tnot applicable APWU00617\tnot applicable APWU00618\tnot applicable APWU00233\tnot applicable APWU00234\tnot applicable APWU00235\tnot applicable APWU00236\tnot applicable APWU00237\tnot applicable APWU00238\tnot applicable APWU01928\t010084068210229221APWU0192811150917 APWU00930\tnot applicable APWU00939\tnot applicable APWU00940\tnot applicable APWU00941\tnot applicable APWU01029\tnot applicable APWU01030\tnot applicable APWU01031\tnot applicable APWU01032\tnot applicable APWU01033\tnot applicable APWU01034\tnot applicable APWU01035\tnot applicable APWU01036\tnot applicable APWU01037\tnot applicable APWU01038\tnot applicable APWU01039\tnot applicable APWU01040\tnot applicable APWU01041\tnot applicable APWU01042\tnot applicable APWU01043\tnot applicable APWU01044\tnot applicable APWU01045\tnot applicable APWU01046\tnot applicable APWU01047\tnot applicable APWU01048\tnot applicable APWU01049\tnot applicable APWU01050\tnot applicable APWU01051\tnot applicable APWU00679\tnot applicable APWU00680\tnot applicable APWU00681\tnot applicable APWU00682\tnot applicable APWU00683\tnot applicable APWU00684\tnot applicable APWU00685\tnot applicable APWU00686\tnot applicable APWU00687\tnot applicable APWU00688\tnot applicable APWU00689\tnot applicable APWU00690\tnot applicable APWU00691\tnot applicable APWU00692\tnot applicable APWU00693\tnot applicable APWU00694\tnot applicable APWU00695\tnot applicable APWU00696\tnot applicable APWU00697\tnot applicable APWU00698\tnot applicable APWU00699\tnot applicable APWU00700\tnot applicable APWU00701\tnot applicable APWU00702\tnot applicable APWU00703\tnot applicable APWU00704\tnot applicable APWU00705\tnot applicable APWU01661\tnot applicable APWU01662\tnot applicable APWU01663\tnot applicable APWU01664\tnot applicable APWU00199\tnot applicable APWU00200\tnot applicable APWU00201\tnot applicable APWU00202\tnot applicable APWU00203\tnot applicable APWU00204\tnot applicable APWU00205\tnot applicable APWU00206\tnot applicable APWU00207\tnot applicable APWU00421\tnot applicable APWU00422\tnot applicable APWU00423\tnot applicable APWU00424\tnot applicable APWU00425\tnot applicable APWU00426\tnot applicable APWU00427\tnot applicable APWU00428\tnot applicable APWU00429\tnot applicable APWU00430\tnot applicable APWU00431\tnot applicable APWU00432\tnot applicable APWU00433\tnot applicable APWU00434\tnot applicable APWU00435\tnot applicable APWU00436\tnot applicable APWU00437\tnot applicable APWU00438\tnot applicable APWU00439\tnot applicable APWU00440\tnot applicable APWU00441\tnot applicable APWU00442\tnot applicable APWU00443\tnot applicable APWU00444\tnot applicable APWU00445\tnot applicable APWU00446\tnot applicable APWU00447\tnot applicable APWU00367\tnot applicable APWU00368\tnot applicable APWU00369\tnot applicable APWU01461\tnot applicable APWU01462\tnot applicable APWU01463\tnot applicable APWU01512\tnot applicable APWU00209\tnot applicable APWU00374\tnot applicable APWU00375\tnot applicable APWU00376\tnot applicable APWU00377\tnot applicable APWU00378\tnot applicable APWU00908\tnot applicable APWU00909\tnot applicable APWU00910\tnot applicable APWU00911\tnot applicable APWU00405\tnot applicable APWU00406\tnot applicable APWU00407\tnot applicable APWU00408\tnot applicable APWU02037\t010084068210229221APWU0203711150929 APWU02038\t010084068210229221APWU0203811150929 APWU02331\t010084068210229221APWU0233111151103 APWU01740\tnot applicable APWU00838\tnot applicable APWU00546\tnot applicable APWU00549\tnot applicable APWU00550\tnot applicable APWU00790\tnot applicable APWU00518\tnot applicable APWU00521\tnot applicable APWU00522\tnot applicable APWU00523\tnot applicable APWU00359\tnot applicable APWU00399\tnot applicable APWU01406\tnot applicable APWU01946\t010084068210229221APWU0194611150918 APWU00706\tnot applicable APWU01833\t010084068210229221APWU0183311150819 APWU00890\tnot applicable APWU01846\t010084068210229221APWU0184611150831 APWU01847\t010084068210229221APWU0184711150831 APWU01848\t010084068210229221APWU0184811150831 APWU01849\t010084068210229221APWU0184911150831 APWU00327\tnot applicable APWU00328\tnot applicable APWU00329\tnot applicable APWU00330\tnot applicable APWU00331\tnot applicable APWU00332\tnot applicable APWU00333\tnot applicable APWU00334\tnot applicable APWU00335\tnot applicable APWU00336\tnot applicable APWU00337\tnot applicable APWU00338\tnot applicable APWU00339\tnot applicable APWU00340\tnot applicable APWU00341\tnot applicable APWU00342\tnot applicable APWU01656\tnot applicable APWU01657\tnot applicable APWU01658\tnot applicable APWU01659\tnot applicable APWU00392\tnot applicable APWU00393\tnot applicable APWU00394\tnot applicable APWU00395\tnot applicable APWU00396\tnot applicable APWU00419\tnot applicable APWU00420\tnot applicable APWU00451\tnot applicable APWU00452\tnot applicable APWU00459\tnot applicable APWU00460\tnot applicable APWU00462\tnot applicable APWU00463\tnot applicable APWU00314\tnot applicable APWU02036\t010084068210229221APWU0203611150929 APWU00792\tnot applicable APWU00793\tnot applicable APWU00461\tnot applicable APWU00851\tnot applicable APWU00852\tnot applicable APWU00853\tnot applicable APWU00854\tnot applicable APWU00855\tnot applicable APWU00856\tnot applicable APWU00857\tnot applicable APWU00858\tnot applicable APWU00859\tnot applicable APWU00860\tnot applicable APWU00861\tnot applicable APWU00862\tnot applicable APWU00863\tnot applicable APWU00239\tnot applicable APWU00453\tnot applicable APWU02154\t010084068210229221APWU0215411151014 APWU02155\t010084068210229221APWU0215511151014 APWU02156\t010084068210229221APWU0215611151014 APWU00175\tnot applicable APWU02353\t010084068210229221APWU0235311151112 APWU02354\t010084068210229221APWU0235411151112 APWU02355\t010084068210229221APWU0235511151112 APWU02356\t010084068210229221APWU0235611151112 APWU02357\t010084068210229221APWU0235711151112 APWU02358\t010084068210229221APWU0235811151112 APWU02359\t010084068210229221APWU0235911151112 APWU02360\t010084068210229221APWU0236011151112 APWU02361\t010084068210229221APWU0236111151112 APWU01513\tnot applicable APWU01514\tnot applicable APWU00249\tnot applicable APWU00379\tnot applicable APWU00380\tnot applicable APWU00381\tnot applicable APWU00382\tnot applicable APWU00383\tnot applicable APWU00384\tnot applicable APWU00385\tnot applicable APWU00386\tnot applicable APWU00387\tnot applicable APWU00388\tnot applicable APWU00389\tnot applicable APWU00390\tnot applicable APWU00798\tnot applicable APWU00837\tnot applicable APWU00220\tnot applicable APWU00221\tnot applicable APWU00547\tnot applicable APWU00548\tnot applicable APWU02255\t010084068210229221APWU0225511151029 APWU02256\t010084068210229221APWU0225611151029 APWU02257\t010084068210229221APWU0225711151029 APWU02258\t010084068210229221APWU0225811151029 APWU02259\t010084068210229221APWU0225911151029 APWU02260\t010084068210229221APWU0226011151029 APWU02261\t010084068210229221APWU0226111151029 APWU02262\t010084068210229221APWU0226211151029 APWU02263\t010084068210229221APWU0226311151029 APWU02264\t010084068210229221APWU0226411151029 APWU02265\t010084068210229221APWU0226511151029 APWU02266\t010084068210229221APWU0226611151029 APWU02267\t010084068210229221APWU0226711151029 APWU02268\t010084068210229221APWU0226811151029 APWU02269\t010084068210229221APWU0226911151029 APWU02270\t010084068210229221APWU0227011151029 APWU02271\t010084068210229221APWU0227111151103 APWU02272\t010084068210229221APWU0227211151103 APWU02273\t010084068210229221APWU0227311151103 APWU02274\t010084068210229221APWU0227411151103 APWU02275\t010084068210229221APWU0227511151103 APWU02276\t010084068210229221APWU0227611151103 APWU02277\t010084068210229221APWU0227711151103 APWU02278\t010084068210229221APWU0227811151103 APWU00228\tnot applicable APWU00229\tnot applicable APWU00230\tnot applicable APWU00231\tnot applicable APWU00232\tnot applicable APWU00831\tnot applicable APWU00832\tnot applicable APWU02335\t010084068210229221APWU0233511151103 APWU02336\t010084068210229221APWU0233611151103 APWU02337\t010084068210229221APWU0233711151103 APWU02338\t010084068210229221APWU0233811151103 APWU02339\t010084068210229221APWU0233911151103 APWU02340\t010084068210229221APWU0234011151103 APWU02341\t010084068210229221APWU0234111151112 APWU02342\t010084068210229221APWU0234211151112 APWU02343\t010084068210229221APWU0234311151112 APWU02344\t010084068210229221APWU0234411151112 APWU00354\tnot applicable APWU00355\tnot applicable APWU00356\tnot applicable APWU00357\tnot applicable APWU00358\tnot applicable APWU00295\tnot applicable APWU00298\tnot applicable APWU00299\tnot applicable APWU00300\tnot applicable APWU00301\tnot applicable APWU00360\tnot applicable APWU01293\tnot applicable APWU01294\tnot applicable APWU01295\tnot applicable APWU00830\tnot applicable APWU00215\tnot applicable APWU00216\tnot applicable APWU00217\tnot applicable APWU00218\tnot applicable APWU00219\tnot applicable APWU01809\t010084068210229221APWU0180911150819 APWU01810\t010084068210229221APWU0181011150819 APWU01811\t010084068210229221APWU0181111150819 APWU01812\t010084068210229221APWU0181211150819 APWU01813\t010084068210229221APWU0181311150819 APWU01650\tnot applicable APWU01651\tnot applicable",
      "firm_fei_number": "2126677",
      "recalling_firm": "GE Medical Systems, LLC",
      "address_1": "3000 N Grandview Blvd",
      "city": "Waukesha",
      "state": "WI",
      "postal_code": "53188-1615",
      "additional_info_contact": "GE Healthcare Service\n800-437-1171",
      "reason_for_recall": "The vacuum suction tubing could be kinked within the machine resulting in suction less than the 20 lpm required by ISO 10079-3. This could result in inadequate suction performance to clear the airway and inadequate ventilation of the patient.",
      "root_cause_description": "Employee error",
      "action": "Consignees were sent a GE Healthcare \"Urgent Medical Device Correction\" GEHC Ref#  34076 letter, dated March 15, 2016.  The letter was addressed to the Chief of Anesthesia / Health Care Administrator / Risk Manager and Director of Biomedical / Clinical Engineering.  The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information.  The letter states that users can continue to use all functions of the device.  However, the vacuum suction option can only be used if it passes the evaluation.  A GE representative will contact customers to arrange for the correction at no cost to the customer.  For questions or concerns regarding this notification, contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.",
      "product_quantity": "952 (488 US; 464 OUS)",
      "distribution_pattern": "Worldwide Distribution -- US, to the states of AZ, CA, DC, FL, GA, ID, IL IN, KY, MD, MI, MN, MO, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WI; and, to the countries of AUSTRALIA, BELGIUM. BOLIVIA, CANADA, CHILE, DENMARK, FINLAND, FRANCE, GERMANY, HUNGARIA, INDIA, IRELAND, JAPAN, KAZAKHSTAN, KOREA, KUWAIT, NETHERLANDS, NEW ZEALAND, SAUDI ARABIA, SPAIN, SWITZERLAND, THAILAND, TURKEY, UNITED ARAB EMIRATES, and UNITED KINGDOM.",
      "openfda": {
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        ],
        "device_name": "Gas-Machine, Anesthesia",
        "medical_specialty_description": "Anesthesiology",
        "regulation_number": "868.5160",
        "device_class": "2"
      }
    }
  ]
}