{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Wayne",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "72652",
      "recalling_firm": "Maquet Cardiovascular Us Sales, Llc",
      "address_1": "45 Barbour Pond Drive",
      "address_2": "N/A",
      "postal_code": "07470",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "United States Nationwide Distribution",
      "recall_number": "Z-0589-2016",
      "product_description": "Maquet HCU 30 Coolant Type R134A Filling weight 250 g 120 V 50-60 Hz 1920 W    Product Usage: The Heater Cooler Unit (HCU) 30 is intended to circulate water through heat exchange circuits to warm or cool a patient during short duration cardiopulmonary bypass procedures lasting 6 hours or less.",
      "product_quantity": "100 Units (distributed in United States)",
      "reason_for_recall": "Failure of the HEATER-COOLER UNIT (HCU 30) Type 2 power supply board. A drop of more than 10% voltage can cause overheating and subsequent failing of the R56 thermistor of the power supply board. Board failure typically occurs when the compressor is switched on (prior to patient use); however, it can occur during patient use. This can shut down the compressor or the entire HCU 30 Type 2 unit.",
      "recall_initiation_date": "20151113",
      "center_classification_date": "20160105",
      "termination_date": "20170407",
      "report_date": "20160113",
      "code_info": "HCU 30 Base Unit 100 - 120 V, Model Number 704629/70103.4371  HCU 30 Base Unit 200 - 240 V, Model Number 704631/70103.4642  HCU 30 Base Unit Canadian/US, Model Number 705501/70103.4653  Heater Cooler Unit 30 with Serial Number <93101480    The affected power supply boards have serial numbers less than 107006001."
    }
  ]
}