{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Cambridge",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "88461",
      "recalling_firm": "Philips North America Llc",
      "address_1": "222 Jacobs St",
      "address_2": "N/A",
      "postal_code": "02141-2289",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "N/A",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO,  MD, MD, NH, NY, OH, TN, TX, VA and the countries of Canada, Mexico, Australia, Austria,  Chile, China, Czech Republic, Denmark, France, Germany, India, Indonesia, Italy, Japan,  Korea, Republic of Lebanon, Netherlands, Romania, Russian Federation, Saudi Arabia,  Spain, Turkey, Ukraine, United Kingdom.",
      "recall_number": "Z-2343-2021",
      "product_description": "Ingenia 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as a  diagnostic device. The system can produce cross-sectional images, spectroscopic images  and/or spectra in any orientation of the internal structure of the head, body or extremities  Model Number: 781342",
      "product_quantity": "3 units US; 17 units OUS",
      "reason_for_recall": "Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury",
      "recall_initiation_date": "20210730",
      "center_classification_date": "20210825",
      "termination_date": "20230725",
      "report_date": "20210901",
      "code_info": "S/N and UDI: 85275 (01)00884838055339(21)85275; 85278 (01)00884838055339(21)85278; 85394 (01)00884838055339(21)85394.  OUS: 85393   (01)00884838055339    85332   (01)00884838055339    85334   (01)00884838055339    85336   (01)00884838055339    85349   (01)00884838055339    85350   (01)00884838055339    85355   (01)00884838055339    85370   (01)00884838055339    85371   (01)00884838055339    85382   (01)00884838055339    85384   (01)00884838055339    85385   (01)00884838055339    85398   (01)00884838055339    85348   (01)00884838055339    85149   (01)00884838055339    85367   (01)00884838055339    85388   (01)00884838055339"
    }
  ]
}