{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "184017",
      "product_res_number": "Z-0430-2021",
      "event_date_initiated": "2020-09-21",
      "event_date_created": "2020-11-06",
      "recall_status": "Terminated",
      "event_date_terminated": "2023-11-13",
      "res_event_number": "86555",
      "product_code": "PJB",
      "k_numbers": [
        "K192775"
      ],
      "product_description": "Niobe ES System, Models 001-006000-1 and 001-006100-1",
      "code_info": "Devices with the following system numbers (serial): 105, 108, 113, 116, 124, 125, 126, 128, 130, 131, 134, 135, 138-142, 144, 147, 149, 154, 158, 162, 163, 169, 170, 172-174, 177-179, 181-183, 185, 187, 189, 190, 192-202, 205, 206, 208-210, 212, 214-222, 224-229, 231, 232, 235-242, 244, 245, 249, 251-256, 258-278, 280-284, 286, 287, 288, 290, and 297",
      "firm_fei_number": "3003084417",
      "recalling_firm": "Stereotaxis Inc",
      "address_1": "4320 Forest Park Ave Ste 100 4320 Forest Park Ave",
      "address_2": "Ste 100",
      "city": "Saint Louis",
      "state": "MO",
      "postal_code": "63108-2979",
      "additional_info_contact": "Adam Miller\n314-678-6100",
      "reason_for_recall": "There is a potential for fire in the inside computer cabinet.",
      "root_cause_description": "Device Design",
      "action": "The firm will be contacting consignees via email and providing an electronic Urgent Field Safety Notice and Customer Reply Form.  Consignees are asked for return the acknowledgement form to the firm within 30 days of receipt.",
      "product_quantity": "121",
      "distribution_pattern": "US and OUS distribution:\nUS - TN, MI, MN, KY, MO, IN, TX, NM, CA, NE, OH, NJ, CT, KS, OR, WA, WI, FL, IL, UT, PA, AZ, NY, GA, ID, OK, CO, LA\n\nOUS - EU, China, Australia, Singapore, Canada, South Africa, and Japan",
      "openfda": {
        "k_number": [
          "K183027",
          "DEN140009",
          "K192775",
          "K193147"
        ],
        "device_name": "Catheter Remote Control System",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.5700",
        "device_class": "2",
        "registration_number": [
          "3003084417"
        ],
        "fei_number": [
          "3003084417"
        ]
      }
    }
  ]
}