{
  "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": "97454",
      "recalling_firm": "GE Medical Systems, LLC",
      "address_1": "3000 N Grandview Blvd",
      "address_2": "",
      "postal_code": "53188-1615",
      "voluntary_mandated": "FDA Mandated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide distribution.",
      "recall_number": "Z-2341-2025",
      "product_description": "GE HealthCare OEC 9800.",
      "product_quantity": "",
      "reason_for_recall": "GE HealthCare has become aware of a non-conformance to 21 CFR 1020.30 (k) in certain OEC 9800 and OEC 9900 Elite C-arm Systems. Specifically, impacted systems are missing the full layer of lead tape in the collimator covers, which will lead to a small increase in radiation exposure to the patient and/or operator. The missing lead tape is not detectable by the user.",
      "recall_initiation_date": "20250702",
      "center_classification_date": "20250822",
      "report_date": "20250903",
      "code_info": "GTIN: 00840682114349",
      "more_code_info": ""
    }
  ]
}