{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "158631",
      "product_res_number": "Z-0001-2018",
      "event_date_initiated": "2017-08-30",
      "event_date_created": "2017-10-02",
      "recall_status": "Terminated",
      "event_date_terminated": "2018-01-24",
      "res_event_number": "78082",
      "product_code": "JAD",
      "k_numbers": [
        "K051055",
        "K090584",
        "K110590",
        "K121653",
        "K130549"
      ],
      "product_description": "Carl Zeiss INTRABEAM PRS 500, product #304534-0000-500.  The firm name on the label is Carl Zeiss Meditec AG, Jena, Germany.\nThe INTRABEAM System is indicated for radiation therapy treatments",
      "code_info": "Intrabeam ser. #6402501246, Ion chamber ser. #SN001254; Intrabeam ser. #6402501241, Ion chamber ser. #SN001745; Intrabeam ser. #6402100932, Ion chamber ser. #SN001994; Intrabeam ser. #6402100958, Ion chamber ser. #SN002096; Intrabeam ser. #6402101042, Ion chamber ser. #SN002265; Intrabeam ser. #6402101029, Ion chamber ser. #SN002270; Intrabeam ser. #6402101034, Ion chamber ser. #SN002302; Intrabeam ser. #6402101105, Ion chamber ser. #SN002651; and Intrabeam ser. #6402101130, Ion chamber ser. #SN002684.",
      "firm_fei_number": "3003481798",
      "recalling_firm": "Carl Zeiss Meditec AG",
      "address_1": "Rudolf-Eber-Str. 11 11 rudolf-eber-str.",
      "city": "Oberkochen",
      "country": "Germany",
      "reason_for_recall": "The device had an incorrect printed calibration value on the calibration certificate.",
      "root_cause_description": "Process control",
      "action": "Zeiss sent a Field Safety Corrective Action letter dated August 30. 2017, to all affected customers via FedEx.  Recall letters were issued by the U.S. Agent on behalf of the /recalling firm on 8/30/2017 via FedEx.   Customers were given the following instructions:\n1.\tA member of the ZEISS service staff will contact you to coordinate the steps to be taken and to schedule the update of your system. Alternatively, you may update the system yourself by following the attached instructions. In case you update the system yourself, a ZEISS service staff member will still be visiting your site to confirm the updated calibration.\n2.\tPlease complete and return the attached response form to acknowledge receipt of this notification.\n\nIf you have question regarding this field safety corrective action, you can contact your ZEISS customer service at 800-442-4020 or by email at iort.meditec.US@zeiss.com with any additional questions. You may also contact me at 925-557-4151 or viet.nguyen@zeiss.com",
      "product_quantity": "9 devices",
      "distribution_pattern": "Nationwide Distribution including AZ, CA, CT, DC, FL, GA, OH, and PA.",
      "openfda": {
        "k_number": [
          "K811528",
          "K050843",
          "K150037",
          "K072683",
          "K190255",
          "K894683",
          "K882484",
          "K130549",
          "K072616",
          "K923584",
          "K241174",
          "K153570",
          "K964947",
          "K780278",
          "K904005",
          "K771817",
          "K122951",
          "K182641",
          "K781084",
          "K962613",
          "K121653",
          "K173425",
          "K980526",
          "K903377",
          "K973315",
          "K090584",
          "K111299",
          "K141343",
          "K131582",
          "K964952",
          "K230611",
          "K123985",
          "K813439",
          "K935209",
          "K874214",
          "K090914",
          "K971074",
          "K854609",
          "K992577",
          "K861431",
          "K250692",
          "K213942",
          "K780157",
          "K051055",
          "K162568",
          "K833560",
          "K844424",
          "K172080",
          "K110590",
          "K063456",
          "K871810",
          "K083734",
          "K132092"
        ],
        "registration_number": [
          "3006017180",
          "3036107971",
          "3030230020",
          "3009732568",
          "3009539885",
          "1181047",
          "3009039068",
          "3004561814",
          "2953359",
          "9611894",
          "3010653929",
          "3023344262",
          "2320968",
          "3005770916",
          "3015232217",
          "1219183",
          "3005562917",
          "3008513398",
          "3032638959",
          "9615010"
        ],
        "fei_number": [
          "3006017180",
          "3036107971",
          "3030230020",
          "3009732568",
          "3009539885",
          "1181047",
          "3009039068",
          "3003481798",
          "3010653929",
          "3002807741",
          "3023344262",
          "3005770916",
          "3015232217",
          "1219183",
          "3000215205",
          "3005562917",
          "3008513398",
          "3032638959",
          "3003318268",
          "3004561814"
        ],
        "device_name": "System, Therapeutic, X-Ray",
        "medical_specialty_description": "Radiology",
        "regulation_number": "892.5900",
        "device_class": "2"
      }
    }
  ]
}