{
  "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": "110036",
      "product_res_number": "Z-0260-2013",
      "event_date_initiated": "2011-10-28",
      "event_date_posted": "2012-11-08",
      "recall_status": "Terminated",
      "event_date_terminated": "2016-07-26",
      "res_event_number": "62271",
      "product_code": "IZW",
      "k_numbers": [
        "K090578"
      ],
      "product_description": "R-30H , Diagnostic X-Ray Beam-Limiting Device.\n\nIn combination with any of below X-ray tubes\n\n0.6/1.2P364DK-85, 0.6/1.2P324DK-125,\n\n0.6/1.2P324DK-85, 0.6/1.2P38DE-85\n\nDevice Model # R-30H.\n\nSubsequent Product Code: IZX\n\nProduct Usage:\nThe device is the beam-limiting device for X-ray Radiography.",
      "code_info": "Device Model #R-30H",
      "firm_fei_number": "1000125362",
      "recalling_firm": "Shimadzu Medical Systems",
      "address_1": "20101 S Vermont Ave",
      "city": "Torrance",
      "state": "CA",
      "postal_code": "90502-1328",
      "additional_info_contact": "310-217-8855 Ext. 139",
      "reason_for_recall": "Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray system and Diagnostic x-ray tube assembly because they do not comply with the Product Performance Standards, 21CFR 1020.30 (m) Beam quality --(1) Half-value layer (HVL), which was revised in 2006.  Certain devices might not comply with the requirements for them in some x-ray generating condition after the revision in 2006.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "Shimadzu sent an Urgent Voluntary Medical Device Recall - Field Safety Notice letters dated September 19, 2012  to all the affected customers.  The letter identifed the description of non-compliance, how to identify the affected products, corrective action plan by Shimadzu and actions to be taken customers.  Customers were instructed to contact their local Shimadzu representative or contact Shimadzu National Technical Support at Shimadzu Medical Systems National Technical Support (800) 228-1429.",
      "product_quantity": "665 units",
      "distribution_pattern": "US Nationwide Distribution",
      "openfda": {
        "k_number": [
          "K810598",
          "K861942",
          "K050092",
          "K920725",
          "K960998",
          "K911127",
          "K843244",
          "K862340",
          "K031597",
          "K091517",
          "K984414",
          "K072780",
          "K101039",
          "K833779",
          "K894142",
          "K810590",
          "K090578",
          "K073124",
          "K093572",
          "K920733",
          "K990423",
          "K083029",
          "K951372"
        ],
        "registration_number": [
          "1418964",
          "3009077524",
          "9613445",
          "3023546785",
          "3008284470",
          "8030233",
          "3010703925",
          "3042175844",
          "2183066",
          "9616047",
          "3007562060",
          "3007137304",
          "3000126629",
          "3021544569",
          "3030220356",
          "9680895",
          "3003768277",
          "2126677"
        ],
        "fei_number": [
          "1418964",
          "3009077524",
          "3023546785",
          "3008284470",
          "3010703925",
          "3002175190",
          "3002808139",
          "3007137304",
          "3042175844",
          "2183066",
          "3007562060",
          "3004839934",
          "3002807880",
          "3000126629",
          "3021544569",
          "3030220356",
          "3003377038",
          "2126677"
        ],
        "device_name": "Collimator, Automatic, Radiographic",
        "medical_specialty_description": "Radiology",
        "regulation_number": "892.1610",
        "device_class": "2"
      }
    }
  ]
}