{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Waukesha",
      "state": "WI",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "97030",
      "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 distribution - US Nationwide and the country of China.",
      "recall_number": "Z-2133-2025",
      "product_description": "SIGNA PET/MR",
      "product_quantity": "N/A",
      "reason_for_recall": "GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. As a result, acoustic levels can exceed 99dB, the limit established by International Electrotechnical Commission (IEC 60601-2-33) when using hearing protection with a Noise Reduction Rating (NRR) of 29dB, as currently required in the Operator Manual.",
      "recall_initiation_date": "20250523",
      "center_classification_date": "20250718",
      "report_date": "20250730",
      "code_info": "GTIN:  00840682105378"
    }
  ]
}