{
  "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": "178008",
      "product_res_number": "Z-0764-2020",
      "event_date_initiated": "2019-11-04",
      "event_date_created": "2019-12-31",
      "recall_status": "Open, Classified",
      "res_event_number": "84309",
      "product_code": "KXJ",
      "k_numbers": [
        "K050190"
      ],
      "product_description": "Apollo, Model Numbers 9784100231, 9784120131, 9784130131 - Product Usage: Apollo table is a remote controlled X-ray system suitable for radiography and fluoroscopy examinations. The system is stationary mounted. The movements of the table and the tube stand are motorized and remotely controlled. Medical purpose is the diagnosis, visualization and documentation of various human diseases or injuries.",
      "code_info": "Serial Numbers: 08020473 11100873 15041446",
      "firm_fei_number": "3002808461",
      "recalling_firm": "Villa Sistemi Medicali S.P.A.",
      "address_1": "Via delle Azalee 3 3 via delle azalee",
      "city": "Buccinasco",
      "country": "Italy",
      "reason_for_recall": "An amendment to the IFU and Service Manual is being issued to prescribe the replacement of the angulation chain after 8 years of service of the of the unit.  After testing, it was found that due to metal fatigue under sever workload conditions, the angulation chain might fail before the expected lifetime of 10 years.",
      "root_cause_description": "Device Design",
      "action": "Urgent Field Safety Notice notification letters dated 10/23/19 were sent to customers.\n\nAction to be taken by the customer/user:\nThe user shall take note of amendment/reinforcement of Instructions for Use (IFU) and Service Manual, attached to this FN and, if it is the case, request a service technician to do the periodic preventive maintenance the user shall replace the attached pages in the User Manual and in the Service Manual, prescribing the periodic replacement of the angulation chain.  Fill the table present in the addendum; In the cell \"Next replacement date\" write the date adding 8 years to the replacement date.\n\nAll the examinations performed on the device before the recall remain valid.\n\nThe IFU and the Service Manual need to be amended to prescribe the replacement of the angulation chain after 8 years of service life of the unit.  \n\nThis notice needs to be passed to all users of Apollo, Apollo DRF, Apollo EZ and to all those who need to be aware within your organisation or to any organisation where the potentially affected devices have been transferred.",
      "product_quantity": "3",
      "distribution_pattern": "US Nationwide distribution in the states of AL, AZ, CA, CO, CT, DC, FL, IA, IL, IN, LA, MA, MD, MI, MN, MO, MS, NJ, NY, OH, OK, PA, TN, TX, UT, and Puerto Rico.",
      "openfda": {
        "k_number": [
          "K874639",
          "K834478",
          "K862144",
          "K790536",
          "K803120",
          "K790743",
          "K955414",
          "K860620",
          "K790783",
          "K811196",
          "K963905",
          "K883155",
          "K951146",
          "K881700",
          "K790692",
          "K811969",
          "K883885",
          "K931724",
          "K781992",
          "K812791",
          "K940696",
          "K820111",
          "K871827",
          "K950442",
          "K050190",
          "K922098",
          "K913121",
          "K926407",
          "K854328",
          "K874934",
          "K950068"
        ],
        "registration_number": [
          "3010326005",
          "3004957147",
          "9613183",
          "2183553",
          "3010949642",
          "3042175844",
          "3000126629",
          "9616047",
          "3013836619",
          "1066635",
          "8010652",
          "1225677",
          "3003768251",
          "2247992",
          "3031563141",
          "8020997",
          "2921578",
          "1418964",
          "3002466018",
          "3014209556",
          "3005778458",
          "9617251",
          "3010890274",
          "3011491794",
          "8021091",
          "3004756607",
          "3008284470",
          "3014680784",
          "3007143268",
          "3003768277"
        ],
        "fei_number": [
          "3010326005",
          "1000208827",
          "3004957147",
          "3001451453",
          "2183553",
          "1841",
          "3010949642",
          "3042175844",
          "3000126629",
          "3013836619",
          "3003184737",
          "1825560",
          "3003768251",
          "3002807880",
          "3031563141",
          "2921578",
          "1418964",
          "1000227792",
          "3002466018",
          "3014209556",
          "3005778458",
          "3002807092",
          "3003377038",
          "3010890274",
          "3011491794",
          "3004756607",
          "3002495042",
          "3002808461",
          "3008284470",
          "3007143268"
        ],
        "device_name": "Table, Radiologic",
        "medical_specialty_description": "Radiology",
        "regulation_number": "892.1980",
        "device_class": "2"
      }
    }
  ]
}