{
  "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": "202808",
      "product_res_number": "Z-0073-2024",
      "event_date_initiated": "2023-08-03",
      "event_date_posted": "2023-10-06",
      "recall_status": "Open, Classified",
      "res_event_number": "92882",
      "product_code": "DWC",
      "k_numbers": [
        "K191402"
      ],
      "product_description": "3T Heater Cooler System, REF: 16-02-85",
      "code_info": "UDI: (01)04033817900528/ Serial Numbers: 20T31334, 20T31336, 20T31366, 20T31391, 20T31375, 20T31322,\n20T31348, 20T31345, 20T31362, 20T31363, 20T31364, 20T31407,\n20T31531, 20T31532, 20T31534, 20T31367, 20T31368, 20T31369,\n20T31370, 20T31371, 20T31372, 20T31373, 20T31386, 20T31387,\n20T31388, 20T31389, 20T31390, 20T31550, 20T31551, 20T31552,\n20T31553, 20T31543, 20T31544, 20T31536, 20T31346, 20T31347,\n20T31361, 20T31365",
      "firm_fei_number": "3002808267",
      "recalling_firm": "LivaNova Deutschland GmbH",
      "address_1": "Lindberghstr. 25 25 lindberghstr.",
      "city": "Munich",
      "country": "Germany",
      "additional_info_contact": "Enrico Milani\n89-323010",
      "reason_for_recall": "The firm's labeling (Quick Reference Guide) contains incorrect information in the maintenance schedule for the Heater-Cooler device.",
      "root_cause_description": "Labeling Change Control",
      "action": "On August 3, 2023 and August 28, 2023, LivaNova issued a \"Urgent Medical Device Correction\" notification to affected consignees via E-Mail. LivaNova asked consignees to take the following actions:\n\nWith the help of Attachment 1 of this letter, identify the location of the 3T Heater-\nCooler device(s) where there may be an incorrect QRG.\n2. Dispose of only the Quick Reference Guide rev 22 (bound of laminated pages). A\nnew copy of the quick reference guide will be delivered to your facility as soon as\npossible.\n3. Check whether the maintenance schedule reported in OI section 6.2.1 was\nfollowed.\nA. In case YES: You do not need to take any further action and you can\ncontinue to use the 3T device according to the OI.\nB. In case NO,\nB.1. Replace the aerosol collection if needed (ref. OI section 5.7.2)\nB.2. Disinfect the water circuit (ref. OI section 6.4)\nB.3. Monitor the water quality (ref. OI section 6.5.2)\nB.4. Remove the system from service until you receive the results of the\nwater quality monitoring.\nB.5. In the case of Acceptable bacteria and NTM count (ref OI section\n6.5.2 paragraph 4) you can continue to use the 3T device according\nto the OI.\nB.6. In case of Unacceptable bacteria and NTM count (ref OI section 6.5.2\nparagraph 4), keep the system out of service, and contact your\nhygiene officer and your authorized service technician. LivaNova can\nprovide an optional Deep Cleaning service for the system free of\ncharge. Please contact your service technician or sales\nrepresentative to request this service.\n\n4. Fill in and sign the Customer Response Form (Attachment 1), and return it by email\nto LivaNova.FSCA@livanova.com or by hand to your LivaNova contact person, to\nconfirm that you have received this letter, you have read and understood its\ncontent, you have disposed the incorrect copy and you have received the corrected\nQRG laminated cards.\n\n6. Please ensure that this Medical Device Correction is communicated to all personnel within your organization who need to be",
      "product_quantity": "37 systems",
      "distribution_pattern": "US Nationwide distribution in the states of CA, IN, GA, NC, TX, AZ, FL, MN, NJ, CO, SC.",
      "openfda": {
        "k_number": [
          "K191402",
          "K896974",
          "K896971",
          "K896975",
          "K071521",
          "K003145",
          "K014016",
          "K883603",
          "K220635",
          "K945720",
          "K873813",
          "K841402",
          "K896972",
          "K130300",
          "K140012",
          "K873924",
          "K896973",
          "K896393",
          "K001520",
          "K212657",
          "K874927",
          "K031544",
          "K822874",
          "K052601",
          "K831677",
          "K102147",
          "K873699",
          "K893940",
          "K810647",
          "K122813"
        ],
        "registration_number": [
          "1723241",
          "3001588119",
          "1828100",
          "1516825",
          "3007899424",
          "1928237",
          "3006073153",
          "1649914",
          "1720929",
          "9611109"
        ],
        "fei_number": [
          "3001588119",
          "1828100",
          "1516825",
          "3007899424",
          "1928237",
          "1000517719",
          "3002808267",
          "3006073153",
          "3001665800",
          "1720929"
        ],
        "device_name": "Controller, Temperature, Cardiopulmonary Bypass",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.4250",
        "device_class": "2"
      }
    }
  ]
}