{
  "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": "53505",
      "product_res_number": "Z-0213-2008",
      "event_date_initiated": "2007-06-25",
      "event_date_posted": "2007-11-08",
      "recall_status": "Terminated",
      "event_date_terminated": "2008-02-04",
      "res_event_number": "38376",
      "product_code": "KPQ",
      "k_numbers": [
        "K851653"
      ],
      "product_description": "Ximatron Digital Imaging (Ximavision), V 7.5.51 with Service Pack (SP), Oncology Information System, Varian Medical Systems",
      "code_info": "Ximatron Digital Imaging v7.5.51.6 SP2, serial numbers: H720441, H720637, H720672, H720702, H720781, H720791, H720804, H720865, H720873, H720894, H720895, H720916, H720932, H720973",
      "firm_fei_number": "2916710",
      "recalling_firm": "Varian Medical Systems Inc",
      "address_1": "911 Hansen Way",
      "city": "Palo Alto",
      "state": "CA",
      "postal_code": "94304",
      "additional_info_contact": "650-424-5731",
      "reason_for_recall": "Unexpected loss of Treatement Field Add-Ons (Wedges, Blocks, etc) during Ximatron simulation. If an unapproved treatment field is created without an MLC, but with an add-on, the add on will be deleted without warning.  If this is not detected and corrected, incorrect dose delivery will occur.",
      "root_cause_description": "Software design",
      "action": "The firm issued an Urgent Medical Device Correction letter to its customers by mail on June 25, 2007.  It informed consignees of the anomaly in the software and workarounds for the issue.  In addition, the firm also stated that they are currently validating a new software modification to repair the problem.",
      "product_quantity": "14 units",
      "distribution_pattern": "Worldwide Distribution-USA (MO and NY medical centers) and countries of Switzerland, Bahrain, Canada, France, Germany, Japan, Norway and Sweden.---",
      "openfda": {
        "k_number": [
          "K953233",
          "K911340",
          "K132045",
          "K971839",
          "K946053",
          "K896353",
          "K885081",
          "K884323",
          "K914926",
          "K780963",
          "K834281",
          "K812726",
          "K894568",
          "K884261",
          "K052361",
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          "K853671",
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          "K021780",
          "K973848",
          "K920506",
          "K013531",
          "K052345",
          "K803124",
          "K854880"
        ],
        "registration_number": [
          "3015232217",
          "1123169",
          "1219183",
          "9617016",
          "3007545404",
          "9611343",
          "2916710"
        ],
        "fei_number": [
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          "1219183",
          "3002806900",
          "1000123143",
          "1000284313",
          "3007545404",
          "2916710"
        ],
        "device_name": "System, Simulation, Radiation Therapy",
        "medical_specialty_description": "Radiology",
        "regulation_number": "892.5840",
        "device_class": "2"
      }
    }
  ]
}