{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "114297",
      "product_res_number": "Z-0406-2013",
      "event_date_initiated": "2012-10-25",
      "event_date_posted": "2012-11-20",
      "recall_status": "Terminated",
      "event_date_terminated": "2012-11-20",
      "res_event_number": "63596",
      "product_code": "JAD",
      "k_numbers": [
        "K090584"
      ],
      "product_description": "INTRABEAM Balloon Applicator Set;\n4.0 cm,\nCarl Zeiss Meditec AG, Oberkochen, Germany\n\nINTRABEAM System is intended for radiation therapy treatments.",
      "code_info": "Part number 304534-7500-002; lot number 540960.",
      "firm_fei_number": "2918630",
      "recalling_firm": "Carl Zeiss Meditec, Inc.",
      "address_1": "5160 Hacienda Dr",
      "city": "Dublin",
      "state": "CA",
      "postal_code": "94568-7562",
      "additional_info_contact": "Judith A. Brimacombe, M.A\n925-557-4616",
      "reason_for_recall": "A manufacturing defect has been identified which could results in the small tube becoming dislodged between the luer fitting and the check valve.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "Carl Zeiss Meditec sent an Important Field Corrective Action letter dated October 25, 2012, to all affected customers.  The letter identified the product, the problem, and the action to be taken by the customer.  Customers were instructed to immediately return the affected product to Carl Zeiss Meditec, Inc.  A Carl Zeiss Meditec representative will contact the customer to schedule a visit to support the removal of the affected product.  For questions customers were instructed to call 925-580-5371 or by email at v.venturo@meditec.zeiss.com.\nFor questions regarding this recall call 925-557-4616.",
      "product_quantity": "36 total, all lots",
      "distribution_pattern": "Nationwide Distribution including IL and MD",
      "openfda": {
        "k_number": [
          "K894683",
          "K923584",
          "K844424",
          "K964947",
          "K241174",
          "K072616",
          "K962613",
          "K162568",
          "K083734",
          "K130549",
          "K250692",
          "K992577",
          "K173425",
          "K090914",
          "K213942",
          "K121653",
          "K871810",
          "K190255",
          "K971074",
          "K150037",
          "K123985",
          "K935209",
          "K874214",
          "K110590",
          "K132092",
          "K904005",
          "K903377",
          "K063456",
          "K230611",
          "K861431",
          "K964952",
          "K781084",
          "K811528",
          "K153570",
          "K172080",
          "K771817",
          "K882484",
          "K780278",
          "K854609",
          "K780157",
          "K050843",
          "K051055",
          "K131582",
          "K833560",
          "K122951",
          "K980526",
          "K141343",
          "K973315",
          "K090584",
          "K182641",
          "K813439",
          "K111299",
          "K072683"
        ],
        "registration_number": [
          "3030230020",
          "3009539885",
          "3005770916",
          "3005562917",
          "2320968",
          "3036107971",
          "3004561814",
          "9611894",
          "9615010",
          "3032638959",
          "3009732568",
          "3008513398",
          "3006017180",
          "2953359",
          "3015232217",
          "1219183",
          "3010653929",
          "3023344262",
          "1181047",
          "3009039068"
        ],
        "fei_number": [
          "3030230020",
          "3009539885",
          "3005770916",
          "3005562917",
          "3036107971",
          "3002807741",
          "3003481798",
          "3004561814",
          "3000215205",
          "3032638959",
          "3009732568",
          "3008513398",
          "3006017180",
          "1219183",
          "3015232217",
          "3010653929",
          "3023344262",
          "1181047",
          "3003318268",
          "3009039068"
        ],
        "device_name": "System, Therapeutic, X-Ray",
        "medical_specialty_description": "Radiology",
        "regulation_number": "892.5900",
        "device_class": "2"
      }
    }
  ]
}