{
  "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": "2026-09-17",
    "results": {
      "skip": 0,
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    {
      "cfres_id": "195919",
      "product_res_number": "Z-1854-2022",
      "event_date_initiated": "2022-07-27",
      "event_date_posted": "2022-09-29",
      "recall_status": "Open, Classified",
      "res_event_number": "90807",
      "product_code": "DXJ",
      "k_numbers": [
        "K173381"
      ],
      "product_description": "Barco Medical Network Adapter, MNA-240, part of the NexxisOR system, Model Numbers: a) K9303078A, b) K9303097A",
      "code_info": "a) K9303078A, UDI 05415334000056, all serial numbers; \nb) K9303097A, UDI 05415334001657, all serial numbers",
      "firm_fei_number": "3013691682",
      "recalling_firm": "BARCO NV",
      "address_1": "Beneluxpark 8500 Beneluxpark",
      "city": "Kortrijk",
      "postal_code": "8500",
      "country": "Bulgaria",
      "reason_for_recall": "installation issues",
      "root_cause_description": "Labeling design",
      "action": "Barco NV began notifying its consignees on about August 29, 2022, via email, about the device malfunction and stated that they would be providing an updated instructions for use (IFU).  The firm followed with a Field Safety Action, via email on the same day, which described the issue, potential risks and a copy of the updated IFU.  The letter requested the following:\n1. Fill out and send back Response Form 1 to Barco Key Account Manager after receipt of this Notice.\n2. Read the updated installation instructions, including the potential risk of wrong installation.\n3. Inform relevant partners and ask them to evaluate if their installations must be adapted.\n4. Fill out and send back Response Form 2 to Barco Key Account Manager after completion of the actions.",
      "product_quantity": "169 devices",
      "distribution_pattern": "US Nationwide distribution in the states of FL, IL, NJ.",
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        "device_name": "Display, Cathode-Ray Tube, Medical",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.2450",
        "device_class": "2"
      }
    }
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}