{
  "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": "Waukesha",
      "state": "WI",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "81348",
      "recalling_firm": "GE Medical Systems, LLC",
      "address_1": "3200 N Grandview Blvd",
      "address_2": "N/A",
      "postal_code": "53188-1693",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide - US Nationwide Distribution in the state of Utah.  International distribution to France, Republic of Korea, and Sweden.",
      "recall_number": "Z-0236-2019",
      "product_description": "SIGNA Architect system    Product Usage:  The Signa Architect system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used. The images produced reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.",
      "product_quantity": "4 units",
      "reason_for_recall": "A small area on the bore surface, which is normally accessible to the patient, can get warm enough to cause a serious burn in the event the patient touches the bore and proper padding is not used.",
      "recall_initiation_date": "20181003",
      "center_classification_date": "20181023",
      "termination_date": "20220527",
      "report_date": "20181031",
      "code_info": "Model number: 5388807-100, Serial number (System ID number ):  U30RF0251B (801588MR3), U30RF0258B (M4040093), U30RF0275B (850270504), U30RF0268B (A020MR05)"
    }
  ]
}