{
  "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": "2026-08-15",
    "results": {
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  "results": [
    {
      "cfres_id": "49679",
      "product_res_number": "Z-0381-2007",
      "event_date_initiated": "2006-11-08",
      "event_date_posted": "2007-02-01",
      "recall_status": "Terminated",
      "event_date_terminated": "2007-06-11",
      "res_event_number": "36963",
      "product_code": "DTQ",
      "k_numbers": [
        "K022947"
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      "product_description": "Terumo Advanced Perfusion System 1 Integrated Centrifugal System Control Unit; Catalog number 801046.",
      "code_info": "Serial numbers 0119, 0123, 0124, 0128, 0135, 0136, 0139, 0140, 0146, 0147, 0148, 0151, 0152, 0157, 0171, 0196, 0197, 0214, 0232, 0241, 0271, 0305, 0310, 0315, 0316, 0318, 0323, 0345, 0346, 0372, 0375, 0376, 0377, 0378 and 0380.",
      "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": "Following installation of software version 1.30 in October 2006, the firm confirmed a complaint that the new software caused a discrepancy in the pump speed calculation and caused the pump to stop during clinical use and a ''connect motor'' message to be displayed.",
      "root_cause_description": "Other",
      "action": "Customers were notified by phone, fax, email or by a Terumo representative of these problems between 11/08/06 and 11/13/06 and instructed to not use the unit until new software had been installed.  All version 1.30 software was replaced and version 1.40 installed prior to 12/4/06.",
      "product_quantity": "35",
      "distribution_pattern": "Nationwide.",
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        "device_name": "Console, Heart-Lung Machine, Cardiopulmonary Bypass",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.4220",
        "device_class": "2"
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