{ "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": "2026-09-12", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "194833", "product_res_number": "Z-1525-2022", "event_date_initiated": "2022-06-27", "event_date_created": "2022-08-19", "recall_status": "Open, Classified", "res_event_number": "90576", "product_code": "CBK", "k_numbers": [ "K201658" ], "product_description": "HAMILTON-C6 Intensive Care Ventilator, REF: 160021", "code_info": "UDI-DI: 07630002808590, Serial Numbers:\n5663,\n6995,\n6907,\n6952,\n7177,\n7772,\n6932,\n6157,\n8658,\n7307,\n5939,\n6858,\n6231,\n8620,\n6349,\n8356,\n6480,\n8322,\n8306,\n9100,\n9101,\n9099,\n9098,\n6219,\n7894,\n7861,\n8003,\n6723,\n7802,\n4833,\n7265,\n7980,\n7666,\n7382,\n6774,\n7358,\n7719,\n6896,\n6925,\n9073,\n9062,\n9298,\n9294,\n9301,\n9292,\n9293,\n9290,\n9300,\n9299,\n9291,\n9231,\n9132,\n9108,\n8310,\n8604,\n8255,\n8599,\n7156,\n8313,\n8344,\n8590,\n8087,\n8348,\n8490,\n8151,\n7174,\n8594,\n8477,\n8122,\n8063,\n9353,\n9230,\n9329,\n9243,\n9235,\n9236,\n9337,\n9228,\n9224,\n9229,\n9225,\n9103,\n8413,\n6149,\n8178,\n8401,\n7827,\n8406,\n8409,\n7826,\n6416,\n7831,\n6280,\n9128,\n9260,\n9257,\n9125,\n9120,\n9259,\n9258,\n9354,\n8325,\n8297,\n7777,\n6212,\n6516,\n6871,\n8099,\n6562,\n8258,\n5679,\n5681,\n7808,\n7115,\n8601,\n7349,\n7130,\n6658,\n7581,\n7819,\n8346,\n6537,\n8235,\n7410,\n6868,\n8049,\n8281,\n7966,\n7787,\n9241,\n9242,\n9054,\n9075,\n9131,\n9121,\n9137,\n9134,\n9133,\n9118,\n6350,\n7122,\n7117,\n6790,\n7614,\n8121,\n7884,\n8102,\n8720,\n8715,\n8726,\n8718,\n8719,\n9248,\n9244,\n9127,\n9138,\n9126,\n8256,\n8371,\n9107,\n9109,\n9036,\n9110,\n9069,\n9063,\n9067,\n8097,\n9129,\n9130,\n9459,\n8723,\n8722,\n8713,\n8702,\n8725,\n8714,\n8727,\n8706,\n8517,\n8717,\n7822,\n8148,\n7695,\n8261,\n7165,\n6944,\n7420,\n6937,\n7150,\n6953,\n7201,\n6965,\n7004,\n7196,\n8849,\n8597,\n8850,\n9106,\n9192,\n9239,\n9237,\n9233,\n8311,\n7898,\n7893,\n6641,\n6505,\n6075,\n7986,\n8005,\n7888,\n7887,\n9535,\n9579,\n9508,\n9576,\n9553,\n9577,\n9578,\n9545,\n9582,\n9590,\n9575,\n7845,\n7740,\n8082,\n8070,\n6671,\n7608,\n6566,\n8535,\n8616,\n7821,\n6579,\n7586,\n7994,\n7066,\n7138,\n9102,\n9105,\n14784,\n8603,\n8846,\n8844,\n8847,\n8845,\n8115,\n7113,\n7809,\n7938,\n7993,\n7252,\n8568,\n7754,\n7033,\n8052,\n6829,\n8249,\n9077,\n9080,\n9076,\n9051,\n9064,\n9081,\n9050,\n9071,\n9091,\n7836,\n7656,\n9124,\n9462,\n9297,\n9325,\n9303,\n8866,\n9348,\n9352,\n9324,\n9227,\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", "firm_fei_number": "3001421318", "recalling_firm": "Hamilton Medical AG", "address_1": "Via Crusch 8 8 via crusch", "city": "Bonaduz", "country": "Switzerland", "additional_info_contact": "41816606010", "reason_for_recall": "Ventilator status indicator board can become loose, which could lead to water ingress (disinfectants) that may lead to technical fault alarms. Multiple technical faults in a short time may force ventilators into Safety Ventilation (blower runs constantly) or Ambient Sate (inspiratory channel/expiratory valves opened; patient breaths room air unassisted) with Panel connection lost message displayed", "root_cause_description": "Device Design", "action": "On 6/27/22 Field Safety Notices were emailed to health care facilities, distributors, and service engineers who were informed to take the following actions:\n\n1)\tIn case of a loose status indicator board observed by the user, the front housing containing the status indicator board shall be replaced. This replacement prevents the water ingress that may lead to ambient state. \n2)\tCheck your affected ventilator and inform the distributor immediately if you detect the loosening of the status indicator board.\n3)\tYour local distributor or service engineer will contact you shortly.\n4)\tLoose status indicator board may not lead immediately to an ambient state, however it shall be replaced immediately to avoid any risk to the patient.\n5)\tAccording to the Operator s manual, make sure to always have an alternative means of ventilation available when using ventilation devices.\n6)\tComplete and return the confirmation sheet.\n\nCustomers with questions can contact the firm: +41 58 610 10 20, techsupport@hamilton-medical.com", "product_quantity": "358", "distribution_pattern": "US nationwide distribution including Puerto Rico.", "openfda": { "k_number": [ "K896381", "K021573", "K915312", "K063806", "K853760", "K040642", "K843424", "K897113", "K864431", "K123149", "K003770", "K841818", 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"Anesthesiology", "regulation_number": "868.5895", "device_class": "2" } } ] }