{
  "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": "159021",
      "product_res_number": "Z-0063-2018",
      "event_date_initiated": "2017-08-23",
      "event_date_created": "2017-11-06",
      "recall_status": "Open, Classified",
      "res_event_number": "78254",
      "product_code": "RCE",
      "product_description": "North Star Imaging Inc. (NSI)   Model X-7000 industrial cabinet x-ray system. \n\nIndustrial x-ray imaging of product hardware",
      "code_info": "Model X-7000",
      "firm_fei_number": "3009067082",
      "recalling_firm": "North Star Imaging Inc",
      "address_1": "19875 S Diamond Lake Rd Ste 10 19875 S Diamond Lake Rd",
      "address_2": "Ste 10",
      "city": "ROGERS",
      "state": "MN",
      "postal_code": "55374-4651",
      "additional_info_contact": "800-635-8392",
      "reason_for_recall": "It was discovered a low-level radiation leak that was  found on the NSI X-7000 system.",
      "root_cause_description": "Radiation Control for Health and Safety Act",
      "action": "North Star Imaging will bring defect into compliance by the following  : \n\nThe Center for Devices and Radiological Health (CDRH) understands that the CAP involving 3 units will consist of the following:\n\n1. All three customers have been notified that the affected products will be repaired free of charge.\n\n2 .The area where the emission rate could be exceeded will have shielding added until emissions are adequately attenuated under the conditions described above.\n\n3. The repaired systems will be completely surveyed to verify compliance with the cabinet x- ray system performance standards emission limit.\n\n4.All repairs will be completed before February 1, 2018.\n\nFor further questions, please call (800) 635-8392.",
      "product_quantity": "US - 3 units",
      "distribution_pattern": "US Distribution to the states of : PA, OH and KS.",
      "openfda": {
        "device_name": "Cabinet X-Ray, Industrial",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "N"
      }
    }
  ]
}