{
  "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": "203903",
      "product_res_number": "Z-0399-2024",
      "event_date_initiated": "2023-10-06",
      "event_date_posted": "2023-11-21",
      "recall_status": "Open, Classified",
      "res_event_number": "93315",
      "product_code": "JAI",
      "k_numbers": [
        "K160518"
      ],
      "product_description": "ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient positioning in Radiation Therapy, Radiology, or Radiology image-guided treatment environment.\nPart Number: 1SOPT00009",
      "code_info": "UDI-DI:(01)03700383510079\nSN 100000004639\nSN 100000004698\nSN 100000004695",
      "firm_fei_number": "3012834372",
      "recalling_firm": "LEONI CIA CABLE SYSTEMS",
      "address_1": "5 avenue Victor Hugo",
      "city": "Chartres",
      "country": "France",
      "reason_for_recall": "Users of the patient positioning system ORION System can be faced with a sudden short-term acceleration or with an unintended short-distance movement when the movements are again allowed after an unforeseen interruption signal of motion may result in a collision of the patient with another stationary component of the treatment room.",
      "root_cause_description": "Software design",
      "action": "BizLink s notified customer via email with delivery and read confirmation and with the Field Safety Notice (FSCA Ref: UMCU-638) on October 6, 2023.  Letter states reason for recall, health risk and action to take:\nBizLink technical support team will contact customers shortly to organize the deployment of the hot fix in the proton-therapy treatment centers.\nWhile waiting for the hot fix, BizLink recommend that customers implement the following action at the customer software level to avoid this problem:\nSend a stopFast command just after reactivating the motionEnable / the E-stop / the collision detection by Safety Laser and before sending any other motion command.\nA hot fix to correct this bug has been developed.\nBizLink shall provide this hot fix (version OSS 6.1 and version OSS 7.3) and the detailed documentation so that customers can deploy the new software version on clinical sites\navailable on October 27, 2023 at the latest.\n\nIf you require further clarification, please feel free to contact our BizLink Team (bfrc_CustomerName@bizlinktech.com).\nPlease return the signed copy of the FSN to BizLink (bfr_vigilance_orion@bizlinktech.com) within 10 working days",
      "product_quantity": "3 units",
      "distribution_pattern": "US Nationwide distribution in the states of MA, TN.",
      "openfda": {
        "k_number": [
          "K231612",
          "K072898",
          "K910002",
          "K122201",
          "K060671",
          "K910971",
          "K855063",
          "K834201",
          "K050422",
          "K120916",
          "K910648",
          "K062639",
          "K170502",
          "K983678",
          "K982446",
          "K837152",
          "K182683",
          "K993522",
          "K071870",
          "K031866",
          "K013036",
          "K033316",
          "K160518",
          "K041448",
          "K122413",
          "K120520",
          "K042146",
          "K034054",
          "K941927",
          "K964740",
          "K060870",
          "K132084"
        ],
        "registration_number": [
          "9710332",
          "3015232217",
          "2247992",
          "3006894636",
          "2436865",
          "3006946288",
          "3012834372",
          "1932738"
        ],
        "fei_number": [
          "3003251135",
          "3015232217",
          "3006894636",
          "1000143606",
          "1000521490",
          "3006946288",
          "1000208827",
          "3012834372"
        ],
        "device_name": "Couch, Radiation Therapy, Powered",
        "medical_specialty_description": "Radiology",
        "regulation_number": "892.5770",
        "device_class": "2"
      }
    }
  ]
}