{
  "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": "2026-05-06",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Plano",
      "state": "TX",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "61554",
      "recalling_firm": "Advanced Neuromodulation Systems Inc.",
      "address_1": "6901 Preston Rd",
      "address_2": "N/A",
      "postal_code": "75024-2508",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution - 53 consignees out of the US.",
      "recall_number": "Z-0894-2013",
      "product_description": "Advanced Neuromodulation Systems, Brio DBS System implantable neurostimulator, IPG or R-IPG,  Model 6788 Implantable Pulse Generator.",
      "product_quantity": "388 units",
      "reason_for_recall": "Unintended Fluid ingress into the device header has been shown.",
      "recall_initiation_date": "20120328",
      "center_classification_date": "20130228",
      "termination_date": "20130815",
      "report_date": "20130306",
      "code_info": "Model number 6788.  All lots manufactured prior to 03/16/2012 are being recalled."
    }
  ]
}