{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Toronto",
      "state": "N/A",
      "country": "Canada",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "81317",
      "recalling_firm": "Synaptive Medical Inc",
      "address_1": "555 Richmond St West, Suite 800",
      "address_2": "N/A",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide - US Nationwide Distribution and the country of Canada",
      "recall_number": "Z-0470-2019",
      "product_description": "BrightMatter Guide, Product Number SYN-0026, Versions: 1.5.0, 1.5.1 and 1.5.2    Product Usage:  BrightMatter Guide can navigate a third-party port (NICO BrainPath device) by attaching Synaptive s custom Tracking Array to the port directly. As the BrainPath is navigable in two configurations (sheath only / sheath and obturator), the tip of the obturator is represented in the software with a tip extension beyond the bottom of the sheath. Note sheath and cannula are used interchangeably in this document.",
      "product_quantity": "37 units",
      "reason_for_recall": "This recall has been initiated due to a software defect found in the Guide System software when used with NICO BrainPath ports under certain circumstances. When one trajectory is set with a blue port and another trajectory is set with a gold port, the software defect is triggered when the user switches between these trajectories during a surgical procedure.",
      "recall_initiation_date": "20181009",
      "center_classification_date": "20181126",
      "termination_date": "20210812",
      "report_date": "20181205",
      "code_info": "Serial Numbers:  0063HJ5Y062          00635F48562          00635GTYK32          00638HTZK32          0063G6DRM12          0063CPBRM12          006395Q2Z52          0063J9BD062          00634X19562          0063GN0B562          00637BP9562          0063JTDW462          00638J89562          006360JV462          0063F1Q2Z52          0063FGWYK32          006384WYK32          00635YH8562          0063C2SKH72          00635NWPK12          0063DKWYK32          006358Q2Z52          0063HM0B562          0063DZPGP12          00634BBD062          00636L48562          0063DD8GP12          0063HCZ1Z52          006318XYK32          0003CZDRLC2          0063GLD6562          0063HRZYK32          006317B8562          006348M5562          0063HGTYK32          0063FHXY062          00634DBD062"
    }
  ]
}