{
  "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": "Saint Paul",
      "state": "MN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "68581",
      "recalling_firm": "Shape Medical Systems, Inc",
      "address_1": "5000 Township Pkwy",
      "address_2": "N/A",
      "postal_code": "55110-5852",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Telephone",
      "distribution_pattern": "Nationwide Distribution",
      "recall_number": "Z-2051-2014",
      "product_description": "Shape HF Cardiopulmonary System.   Made up of Shape HF System Analyzer (PN 0001-9001) and Disposable Patient Interface (DPI), (PN 0004-4001).  A pulmonary gas exchange testing system used during cardiopulmonary exercise testing where collection and review of gas exchange variables are indicated.  The system will provide physiological data to physicians to aid in  patient assessment.",
      "product_quantity": "800",
      "reason_for_recall": "Shape Medical has initiated a correction due to a mandatory software upgrade for the Shape HF Cardiopulmonary Testing System prior to use of the impacted DPI lot numbers.  Use of the incorrect software version with the impacted DPIs could result in erroneous testing results potentially leading to incorrect diagnosis and incorrect treatment.",
      "recall_initiation_date": "20140528",
      "center_classification_date": "20140714",
      "termination_date": "20150522",
      "report_date": "20140723",
      "code_info": "DPIs with Lot Number 1405006 and higher."
    }
  ]
}