{
  "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-2341-2021",
      "product_description": "Ingenia 1.5T Evoluton- 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: 781315",
      "product_quantity": "2 units US; 16 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: US: 61044 (01)00884838099715(21)61044; 61047 (01)00884838099715(21)61047.  OUS:  61028 (01)00884838099715  61008 (01)00884838099715  61025 (01)00884838099715 61026 (01)00884838099715  61034 (01)00884838099715  61035 (01)00884838099715  61042 (01)00884838099715  61046 (01)00884838099715 61040 (01)00884838099715 61041 (01)00884838099715  61018 (01)00884838099715  61017 (01)00884838099715  61032 (01)00884838099715  61043 (01)00884838099715  61033 (01)00884838099715  61064 (01)00884838099715"
    }
  ]
}