{
  "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": "94640",
      "product_res_number": "Z-0163-2011",
      "event_date_initiated": "2010-09-17",
      "event_date_posted": "2010-10-28",
      "recall_status": "Terminated",
      "event_date_terminated": "2010-11-10",
      "res_event_number": "56852",
      "product_code": "IWB",
      "k_numbers": [
        "K092083"
      ],
      "product_description": "Leksell Gamma Knife Perfexion with EXTEND Frame System, manufactured by Electa Instrument AB, Stockholm, Sweden.",
      "code_info": "Model #1009633 - Serial Numbers 6004, 6032 and 6078",
      "firm_fei_number": "1037831",
      "recalling_firm": "Elekta, Inc.",
      "address_1": "4775 Peachtree Industrial Blvd",
      "address_2": "Bldg 300 #300",
      "city": "Norcross",
      "state": "GA",
      "postal_code": "30092-3011",
      "additional_info_contact": "Thomas Valentine\n770-670-2548",
      "reason_for_recall": "The anterior fixation bar of the EXTEND mouthpiece frontpiece may separate from the dental impression tray. This may result in reduced treatment accuracy.",
      "root_cause_description": "Other",
      "action": "Elekta issued an Important Notice: Urgent Field Safety Notice dated September 17, 2010 concerning Field Change Order 10000202003-A342 \"Important Notice regarding recall of mouthpieces for EXTEND system,  to all users of the EXTEND system for LGK Perfexion. the letter identified the issue and associated potential hazard, and requested the identification and return of all affected mouthpieces, and confirmation of receipt of the letter. Elekta will arrange return and replacement through local service representatives.\nCustomers can contact Elekta concerning this recall at 770 300 9725.",
      "product_quantity": "3 units",
      "distribution_pattern": "Nationwide Distribution: to the states of MO, VA, and WA.",
      "openfda": {
        "k_number": [
          "K000478",
          "K133565",
          "K984328",
          "K924849",
          "K120811",
          "K925133",
          "K131777",
          "K102533",
          "K180571",
          "K151159",
          "K173789",
          "K150191",
          "K061941",
          "K250391",
          "K200050",
          "K970647",
          "K222047",
          "K060314",
          "K827583",
          "K053485",
          "K092083",
          "K001006",
          "K894165",
          "K142219",
          "K860849",
          "K190844",
          "K061540",
          "K041125",
          "K063512",
          "K160440",
          "K914808",
          "K051022",
          "K151561",
          "K964606",
          "K232854",
          "K863180",
          "K983917",
          "K960892",
          "K203146",
          "K780948",
          "K850543",
          "K173791",
          "K172706",
          "K203250",
          "K871215",
          "K973441",
          "K984563",
          "K912250"
        ],
        "registration_number": [
          "1038814",
          "9617016",
          "3015621321",
          "3020999824",
          "3015620182",
          "3015232217",
          "3006946288",
          "3014273653",
          "3005136058",
          "2939248"
        ],
        "fei_number": [
          "1038814",
          "3002806900",
          "3015621321",
          "3020999824",
          "3015620182",
          "3015232217",
          "3006946288",
          "3014273653",
          "3005136058",
          "2939248"
        ],
        "device_name": "System, Radiation Therapy, Radionuclide",
        "medical_specialty_description": "Radiology",
        "regulation_number": "892.5750",
        "device_class": "2"
      }
    }
  ]
}