{
  "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": "2026-08-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "205111",
      "product_res_number": "Z-0750-2024",
      "event_date_initiated": "2023-11-30",
      "event_date_posted": "2024-01-18",
      "recall_status": "Open, Classified",
      "res_event_number": "93684",
      "product_code": "IWB",
      "k_numbers": [
        "K172706",
        "K180571"
      ],
      "product_description": "GammaPod - Treatment Planning System-a component of the GammaPod Irradiation System. \nRef: XMSGP030A09.07-0.01\n\nIntended for use in the noninvasive stereotactic delivery of a radiation dose to a partial volume of the breast in conjunction with breast conserving treatment.",
      "code_info": "00850002615029(11)230321(21)TPS0018 (Distributed in the US)\n00850002615029(11)230629(21)TPS0013 (Distributed in the US)\n00850002615005(11)21H24(21)TPS0016 (Distributed in the US)\n\n00850002615029(11)210629(21 )TPS0014 (Italy)",
      "firm_fei_number": "3014273653",
      "recalling_firm": "Xcision Medical Systems, LLC",
      "address_1": "9176 Red Branch Rd Ste O 9176 Red Branch Rd",
      "address_2": "Ste O",
      "city": "Columbia",
      "state": "MD",
      "postal_code": "21045-2001",
      "additional_info_contact": "Michelle Crawley \n443-681-7500",
      "reason_for_recall": "Wrong structures imported into the GammaPod Treatment Planning System.-system allowed an RTSS generated from a previous CT scan to be selected",
      "root_cause_description": "Software design",
      "action": "Xcision issued Urgent Field Correction Letter via email on 11/30/23. Letter states reason for recall, health risk and action to take:\nPlease post this notification internally for awareness of GammaPod BY CUSTOMER/USER Treatment Planning System users. Xcision is working on an update to the TPS software to implement controls to identify not only the patient identification but also the series\nof which the structures were delineated. This change is expected for\nimplementation in early 2024. If you need any further information or support concerning this issue,  please contact Xcision Customer Support at 855-924-7466 (1-855-\nSUPPORT XCISION).",
      "product_quantity": "4 units",
      "distribution_pattern": "Worldwide - US Nationwide distribution in the states of MD, PA, TX and the country of Italy.",
      "openfda": {
        "k_number": [
          "K053485",
          "K925133",
          "K827583",
          "K150191",
          "K102533",
          "K203250",
          "K051022",
          "K973441",
          "K190844",
          "K912250",
          "K173791",
          "K871215",
          "K780948",
          "K000478",
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          "K924849",
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          "K041125",
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          "K222047",
          "K232854",
          "K133565",
          "K120811",
          "K983917",
          "K131777",
          "K060314",
          "K960892",
          "K151561",
          "K964606",
          "K250391",
          "K172706",
          "K970647",
          "K850543",
          "K063512",
          "K001006",
          "K092083",
          "K061540",
          "K151159",
          "K860849",
          "K180571",
          "K061941",
          "K914808",
          "K203146",
          "K142219",
          "K984563",
          "K863180"
        ],
        "registration_number": [
          "3006946288",
          "3020999824",
          "2939248",
          "3015620182",
          "3015232217",
          "1038814",
          "3015621321",
          "3014273653",
          "3005136058",
          "9617016"
        ],
        "fei_number": [
          "3006946288",
          "3020999824",
          "2939248",
          "3015620182",
          "3002806900",
          "3015232217",
          "3015621321",
          "1038814",
          "3014273653",
          "3005136058"
        ],
        "device_name": "System, Radiation Therapy, Radionuclide",
        "medical_specialty_description": "Radiology",
        "regulation_number": "892.5750",
        "device_class": "2"
      }
    }
  ]
}