{
  "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": "2026-08-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "48594",
      "product_res_number": "Z-0598-2007",
      "event_date_initiated": "2005-11-01",
      "event_date_posted": "2007-06-30",
      "recall_status": "Terminated",
      "event_date_terminated": "2009-06-23",
      "res_event_number": "36399",
      "product_code": "DTQ",
      "k_numbers": [
        "K022947"
      ],
      "product_description": "Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required) base; Model 801763.",
      "code_info": "Serial numbers 0011 through 0363 may be affected.  Serial numbers 0011, 0014, 0023, 0038, 0043, 0047, 0119, 0145, 0245, 0253, 0254, 0256, 0260, 0265, 0278, 0280, 0284, 0295, 0305, 0310, 0317, 0333, 0341, 0343, 0351, 0356 and 0360 have been corrected and the other serial numbers listed will be corrected.",
      "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": "The power manager subsystem may not initialize properly during start-up, which will cause the battery status monitoring and battery switching operations to not be fully functional.",
      "root_cause_description": "Other",
      "action": "Firm repaired the affected units beginning in November 2005, upon receipt of complaints of failure.  The firm issued a Device Correction Letter dated 6/6/07 notifying all users of the problem and advising them that they will be visited and their units upgraded as replacement components become available.",
      "product_quantity": "485 of both model numbers",
      "distribution_pattern": "Worldwide distribution ---- Nationwide and countries of Australia, Belgium, Canada, Dominican Republic, Egypt, Germany, Hong Kong, India, Indonesia, Japan, Malaysia, Mexico, Pakistan, Philippines, Republic of Georgia, Russia and Saudi Arabia.",
      "openfda": {
        "k_number": [
          "K090006",
          "K173834",
          "K813034",
          "K770002",
          "K822068",
          "K080832",
          "K102726",
          "K842138",
          "K915183",
          "K052555",
          "K002118",
          "K221895",
          "K093882",
          "K092463",
          "K091007",
          "K060053",
          "K190282",
          "K851614",
          "K202125",
          "K030141",
          "K070213",
          "K163531",
          "K172220",
          "K942582",
          "K062396",
          "K022947",
          "K002116",
          "K153376",
          "K801097",
          "K943803",
          "K870976",
          "K851615",
          "K863541",
          "K871131",
          "K950990",
          "K071318",
          "K232291",
          "K982014",
          "K103762",
          "K863960",
          "K772001",
          "K131041",
          "K964017",
          "K861388",
          "K011088",
          "K133598",
          "K210130",
          "K020571",
          "K021694",
          "K151349",
          "K221373",
          "K862973"
        ],
        "registration_number": [
          "3011554160",
          "3005941719",
          "8010762",
          "1828100",
          "3019807891",
          "2184009",
          "9680841",
          "1218444",
          "3002807090",
          "2916596",
          "3001589655",
          "3010703925",
          "3009507273",
          "3007427881",
          "3006073153",
          "9611109",
          "3010163695",
          "3042990265"
        ],
        "fei_number": [
          "3006003617",
          "3011554160",
          "3005426550",
          "3009649876",
          "1828100",
          "3019807891",
          "3002808267",
          "1218444",
          "3002807111",
          "1000116158",
          "2916596",
          "3001589655",
          "3010703925",
          "3006073153",
          "3009507273",
          "3007427881",
          "3010163695",
          "3042990265"
        ],
        "device_name": "Console, Heart-Lung Machine, Cardiopulmonary Bypass",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.4220",
        "device_class": "2"
      }
    }
  ]
}