{
  "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": "Kalona",
      "address_1": "102 1st St S",
      "reason_for_recall": "The general purpose electromagnetic sensor was incorrectly calibrated causing potential variability in the projected position of the needle path with the ultrasound device.",
      "address_2": "",
      "product_quantity": "30 kits",
      "code_info": "Lot numbers M867430 and M873080",
      "center_classification_date": "20120706",
      "distribution_pattern": "Worldwide Distribution - USA including WI, CA, MA, IN, WA, and NJ.  Foreign distribution was made to Germany, Canada, Denmark, Hong Kong, Ukraine, Japan, Italy, Korea, and France.",
      "state": "IA",
      "product_description": "CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromagnetic sensor for use with 3D Guidance driveBAY, driveBAY 2, trakSTAR, or trakSTAR2 trackers, Ref. 10441627.   The firm name on the label is CIVCO, Kalona, IA.  The kit contains sensor component part number 410-240.    The general purpose sensor within the kit is intended to provide physicians with tools for electromagnetic tracking of instruments with respect to image data. The sensors are designed to attach to custom reusable tracking bracket for leading transducers and other medical devices",
      "report_date": "20120718",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Civco Medical Instruments Inc",
      "recall_number": "Z-1953-2012",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "product_type": "Devices",
      "event_id": "61793",
      "termination_date": "20150107",
      "more_code_info": "",
      "recall_initiation_date": "20120507",
      "postal_code": "52247-9589",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}