{
  "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": "29894",
      "product_res_number": "Z-0078-04",
      "event_date_initiated": "2003-10-03",
      "event_date_posted": "2003-10-31",
      "recall_status": "Terminated",
      "event_date_terminated": "2004-07-20",
      "res_event_number": "27447",
      "product_code": "FFK",
      "k_numbers": [
        "K012445"
      ],
      "product_description": "LithoClast Foot Pedal, reference EK-166  \nCatalog Number: 840-703\nUsed as an accessory to the EMS Swiss LithoClast Master/Ultra, Catalog No 840-700.. Manufactured by EMS Electro Medical Systems S, Nyon, Switzerland. Distributed by Boston Scientifc/Microvasive,Natick, MA",
      "code_info": "Units shipped prior to 3/03",
      "firm_fei_number": "3004096429",
      "recalling_firm": "Electro Medical Systems (EMS SA)",
      "address_1": "Rte de Champ-Colin 2 2 rte de champ-colin",
      "city": "Nyon",
      "country": "Switzerland",
      "additional_info_contact": "Robert Miragliuolo\n508-650-8156",
      "reason_for_recall": "Failure of foot pedal to activate device",
      "root_cause_description": "Other",
      "action": "EMS notified US Distributor Boston Scientific by letter dated 10/3/03 advising them to to determine the client base and provide replacement foot pedals to the final user. Boston Scientific/Microvasive notified Hospital Risk Managers by letter dated 10/6/03.Sales representatives will visit accounts to replace the foot pedal.",
      "product_quantity": "96 units",
      "distribution_pattern": "Nationwide\nGovernment: VA Hospitals:Decatur, GA;Biloxi, MS; Omaha,NB, Oklahoma CIty, OK;Muskogee, OK, West Palm Beach, FL \nWalter Reed Army Medical Center, Washington, DC",
      "openfda": {
        "k_number": [
          "K883189",
          "K830086",
          "K951531",
          "K914516",
          "K852874",
          "K162119",
          "K160198",
          "K834228",
          "K931779",
          "K230488",
          "K002084",
          "K913487",
          "K012445",
          "K243032",
          "K832566",
          "K072422",
          "K123038",
          "K990341",
          "K132795",
          "K885255",
          "K822585",
          "K863642",
          "K880503",
          "K011848",
          "K822644",
          "K963285",
          "K980492",
          "K202813",
          "K120303",
          "K111058",
          "K062475",
          "K914517",
          "K894704",
          "K102169",
          "K011911",
          "K864904",
          "K905553",
          "K092033",
          "K992114",
          "K973788",
          "K925396",
          "K923822",
          "K920410",
          "K130368",
          "K242888",
          "K052135",
          "K895178",
          "K913955",
          "K974164",
          "K992251",
          "K914515",
          "K011065",
          "K890436",
          "K981233",
          "K914514",
          "K802322",
          "K903337",
          "K931755",
          "K944571",
          "K974796",
          "K191124"
        ],
        "registration_number": [
          "3002807616",
          "9610617",
          "3010707607",
          "1000121056",
          "1225687",
          "3005099803",
          "1000161819",
          "3005987240",
          "3034630389",
          "3009217531",
          "3006546082",
          "1519132",
          "8030987",
          "3004096429",
          "1825146",
          "9611102",
          "2124215",
          "1648564",
          "1423662",
          "3011050570",
          "3006617533",
          "2183744",
          "3014342096",
          "3003790304",
          "2028632",
          "1828132",
          "3010202439",
          "9614434",
          "1314417",
          "1450997",
          "9681260",
          "1418479",
          "2528981",
          "2020550",
          "1820334",
          "3009543101"
        ],
        "fei_number": [
          "3002807616",
          "3010707607",
          "1000121056",
          "3005099803",
          "3002808268",
          "1000161819",
          "1000125025",
          "3005987240",
          "3034630389",
          "3009217531",
          "3001451463",
          "3006546082",
          "1519132",
          "3004096429",
          "3007475226",
          "1825146",
          "2124215",
          "3000205943",
          "3011050570",
          "3002806565",
          "3006617533",
          "2183744",
          "3014342096",
          "3003790304",
          "1828132",
          "3002808273",
          "3002806910",
          "1314417",
          "3000215273",
          "1450997",
          "1418479",
          "2528981",
          "2020550",
          "3002808001",
          "1820334",
          "3009543101"
        ],
        "device_name": "Lithotriptor, Electro-Hydraulic",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.4480",
        "device_class": "2"
      }
    }
  ]
}