{
  "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": "2026-09-10",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "217616",
      "product_res_number": "Z-0923-2026",
      "event_date_initiated": "2025-11-18",
      "event_date_posted": "2025-12-22",
      "recall_status": "Open, Classified",
      "res_event_number": "98101",
      "product_code": "IZF",
      "k_numbers": [
        "K183275"
      ],
      "product_description": "Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic\nCommon Name: DR 800",
      "code_info": "N/A",
      "firm_fei_number": "3001236302",
      "recalling_firm": "AGFA Healthcare Corp.",
      "address_1": "10 S Academy St",
      "city": "Greenville",
      "state": "SC",
      "postal_code": "29601-2632",
      "additional_info_contact": "864-421-1815",
      "reason_for_recall": "It is possible to exceed the maximum allowed Air Kerma rate (AKR) of 88mGy/min for pulsed fluoro\nexams. This can happen in case the framerate is increased on the NX workstation when ABS is not\nenabled.",
      "root_cause_description": "Radiation Control for Health and Safety Act",
      "action": "AGFA NV notified Customers via a letter titled \"IMPORTANT PRODUCT INFORMATION LETTER / DR 800\", included Product Name, Symptom, Cause, Actions to be taken customer and manufacturers respectively: \"Always enable ABS for pulsed fluoro exams.\nActions being taken by the manufacturer:\nAgfa/local business partner will contact you to install a new generator software.\"",
      "product_quantity": "35",
      "distribution_pattern": "U.S. Nationwide distribution.",
      "openfda": {
        "k_number": [
          "K193262",
          "K780995",
          "K013620",
          "K222934",
          "K221949",
          "K790765",
          "K771549",
          "K792067",
          "K852768",
          "K884650",
          "K810274",
          "K944967",
          "K771297",
          "K771296",
          "K925302",
          "K213081",
          "K761004",
          "K183275",
          "K945749",
          "K924443",
          "K931815",
          "K811197",
          "K132261",
          "K810307",
          "K942175",
          "K780319",
          "K011290",
          "K252649",
          "K121499",
          "K973834",
          "K252133",
          "K792327",
          "K890351",
          "K781531",
          "K973864",
          "K811302",
          "K250850",
          "K790132",
          "K834288",
          "K950571",
          "K242395",
          "K892653"
        ],
        "registration_number": [
          "3008496839",
          "3027605321",
          "3031503890",
          "9613152",
          "9613445",
          "3015276088",
          "3001556265",
          "3011825597",
          "9616047",
          "3014018042",
          "2243057",
          "8020997",
          "3008284470",
          "3023003446",
          "3013541324",
          "3003775006",
          "3009963139",
          "3022810909",
          "2126677",
          "3013679558",
          "3001722928"
        ],
        "fei_number": [
          "3008496839",
          "3003377038",
          "3027605321",
          "3031503890",
          "3015276088",
          "3001556265",
          "3011825597",
          "3002807092",
          "3014018042",
          "2243057",
          "3003772616",
          "3008284470",
          "3002175190",
          "3023003446",
          "3013541324",
          "3003775006",
          "3009963139",
          "3022810909",
          "2126677",
          "3013679558",
          "3001722928"
        ],
        "device_name": "System, X-Ray, Tomographic",
        "medical_specialty_description": "Radiology",
        "regulation_number": "892.1740",
        "device_class": "2"
      }
    }
  ]
}