{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "48586",
      "product_res_number": "Z-0332-2007",
      "event_date_initiated": "2004-10-12",
      "event_date_posted": "2006-12-30",
      "recall_status": "Terminated",
      "event_date_terminated": "2007-02-01",
      "res_event_number": "36396",
      "product_code": "DTQ",
      "k_numbers": [
        "K022947"
      ],
      "product_description": "Terumo Advanced Perfusion System 1 Temperature Monitoring System; Catalog number 802114.",
      "code_info": "Serial numbers 00019 through 00034, 00036, 00037, 00046 through 00053, 00055 through 00069, 00073 through 00114, 00116 through 00128, 00131 through 00193, 00195 through 00203, 00205 through 00334, 00339 through 00355, 00357 through 00414, 00416 through 00431. 00434, 00435, 00439 through 00447, 00448 through 00466, 00468 through 00473, 00475 through 00477, 00479 through 00582, 00584 through 00590, 00592 through 00594 and 00606.",
      "firm_fei_number": "1828100",
      "recalling_firm": "Terumo Cardiovascular Systems Corp",
      "address_1": "6200 Jackson Rd",
      "city": "Ann Arbor",
      "state": "MI",
      "postal_code": "48103-9586",
      "additional_info_contact": "800-521-2818",
      "reason_for_recall": "Device module(s) may fail to properly initialize during start up, thus resulting in that  single module being inoperable and a red 'X' being displayed on the monitor screen.",
      "root_cause_description": "Other",
      "action": "U.S. consignees were sent an addendum to the operators manual on October 12, 2004 instructing them to cycle power to the unit to clear the error.  International distributors were requested to provide this information to their customers on 12/15/04, but Terumo has not yet received confirmation that this was completed.",
      "product_quantity": "4,740 for all affected products",
      "distribution_pattern": "Worldwide Distribution-USA and countries Australia, Belgium, Canada, China, Dominican Republic, Egypt, Germany, India, Indonesia, Japan, Malaysia, Mexico, Pakistan, Republic of China, Singapore, South Africa, South Korea, Thailand and United Arab Emirates.",
      "openfda": {
        "k_number": [
          "K870976",
          "K022947",
          "K221373",
          "K172220",
          "K942582",
          "K091007",
          "K133598",
          "K002116",
          "K915183",
          "K232291",
          "K801097",
          "K842138",
          "K093882",
          "K102726",
          "K822068",
          "K982014",
          "K863541",
          "K851615",
          "K080832",
          "K772001",
          "K163531",
          "K221895",
          "K770002",
          "K813034",
          "K210130",
          "K950990",
          "K871131",
          "K090006",
          "K103762",
          "K173834",
          "K002118",
          "K202125",
          "K070213",
          "K060053",
          "K062396",
          "K071318",
          "K021694",
          "K153376",
          "K020571",
          "K964017",
          "K030141",
          "K862973",
          "K131041",
          "K851614",
          "K011088",
          "K863960",
          "K861388",
          "K943803",
          "K052555",
          "K092463",
          "K151349",
          "K190282"
        ],
        "registration_number": [
          "9611109",
          "3019807891",
          "3002807090",
          "1828100",
          "3011554160",
          "3007427881",
          "8010762",
          "3042990265",
          "3009507273",
          "3010163695",
          "3006073153",
          "3001589655",
          "3010703925",
          "1218444",
          "3005941719",
          "2916596",
          "9680841",
          "2184009"
        ],
        "fei_number": [
          "3010703925",
          "3019807891",
          "1828100",
          "3011554160",
          "3007427881",
          "3009649876",
          "3042990265",
          "3002807111",
          "3009507273",
          "3010163695",
          "3005426550",
          "1000116158",
          "3006073153",
          "3001589655",
          "3006003617",
          "1218444",
          "2916596",
          "3002808267"
        ],
        "device_name": "Console, Heart-Lung Machine, Cardiopulmonary Bypass",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.4220",
        "device_class": "2"
      }
    }
  ]
}