{
  "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": [
    {
      "status": "Terminated",
      "city": "Toronto",
      "state": "N/A",
      "country": "Canada",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "72747",
      "recalling_firm": "Synaptive Medical, Inc.",
      "address_1": "101 College Street, Suite 200",
      "address_2": "MaRS Centre, South Tower",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US: FL, WI, IL, LA, WA.",
      "recall_number": "Z-0480-2016",
      "product_description": "Synaptive Medical BrightMatter Navigator System (Guide System). Part number SYN-0026.  The Guide system is comprised of a cart labelled SYN-0024 and a cart labelled SYN-0025, Operator Cart.   A planning and intraoperative guidance system to enable open and percutaneous computer assisted surgery. The system is indicated for medical conditions requiring neurosurgical cranial procedures. It can be used for intra-operative guidance where a reference to a rigid anatomical structure can be identified.",
      "product_quantity": "8",
      "reason_for_recall": "Out of tolerance for radio frequency emissions. At the 150-1000MHz frequency, the testing indicated the BrightMatter Navigation system was up to 20dB uV/meter higher than the applicable IEC 60601-1-2:2007 (Ed3.0) standard specification.",
      "recall_initiation_date": "20151204",
      "center_classification_date": "20151223",
      "termination_date": "20160304",
      "report_date": "20151230",
      "code_info": "00260001   00260002  00260006  00260007  00260005  00260003  00260004  00260012"
    }
  ]
}