{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Ann Arbor",
      "state": "MI",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "63543",
      "recalling_firm": "Terumo Cardiovascular Systems Corporation",
      "address_1": "6200 Jackson Road",
      "address_2": "N/A",
      "postal_code": "48103-9586",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution--USA (nationwide) including the states of  AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, and WV.",
      "recall_number": "Z-0436-2013",
      "product_description": "220/240V AC, Advanced Perfusion System Platform (APS)    The Terumo¿ Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.",
      "product_quantity": "1647 units total",
      "reason_for_recall": "Terumo Cardiovascular System (TCVS) has received reports of a situation where users  experienced a total loss of functionality for some System 1 units. The reports indicate that the  units went blank and shut down with no sign of power and battery backup did not initiate. The  result is all pumps stop, with no safety system functionality, and the battery would not be  activated. The user would be",
      "recall_initiation_date": "20121114",
      "center_classification_date": "20121127",
      "termination_date": "20130830",
      "report_date": "20121205",
      "code_info": "Catalog number: 801764 and all serial numbers"
    }
  ]
}