{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Littleton",
      "address_1": "300 Foster St",
      "reason_for_recall": "Review of on-system electronic product labeling and Instructions for comply with applicable Use in response to a customer inquiry uncovered gaps in compliance FDA standards with the requirements for information to be provided to users in 21CFR 1020.30(h)",
      "address_2": "",
      "product_quantity": "449 in US",
      "code_info": "Model No. BI-700-00027 and BI-700-00028  Serial number range: 00102 through 00753  and B13080721, B13080722, B13090729, B13120763, B13120764, B13120766, B13120768, B13120769",
      "center_classification_date": "20140228",
      "distribution_pattern": "USA (nationwide) Distribution",
      "state": "MA",
      "product_description": "Medtronic O-arm Imaging System Mobile X-ray system.  Model No. BI-700-00027 and BI-700-00028    The 0-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. The 0-ann Imaging System is compatible with certain Image Guided Surgery Systems.",
      "report_date": "20140312",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Medtronic Navigation, Inc.",
      "recall_number": "Z-0973-2014",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "67363",
      "termination_date": "20190417",
      "more_code_info": "",
      "recall_initiation_date": "20130725",
      "postal_code": "01460-2017",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}