{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Hochdorf",
      "state": "",
      "country": "Switzerland",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "81749",
      "recalling_firm": "Swissray Medical AG",
      "address_1": "Turbistrasse 25-27",
      "address_2": "",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution: US distribution to states of: IL and MA and countries of: Czech Republic, Germany, Poland and Peru.",
      "recall_number": "Z-0697-2019",
      "product_description": "ddRCombi Plus FP, Model Number 8.2000.0070.0 (US Version), 8.2000.0060.0 (Europe Version)    The ddRCombi Plus FP is a fully digital, multifunctional X-ray system that allows the direct digitization of X-ray information without use of cassettes or other media. It can perform all applications in orthopedics and trauma as well as pulmonary imaging.",
      "product_quantity": "3",
      "reason_for_recall": "A component of the device was recalled by a supplier. In rare cases of inadequate maintenance or very high clinical workload, the first steel wire rope  of the lifting column, which is designed to take the load, can break without triggering the safety  lock. This can lead to overloading of the safety cable, which is not designed to permanently carry  the load of the lifting column or continuously move under load. This could cause material  fatigue and cause the arm to drop unexpectedly during patient positioning. If the arm drops  unexpectedly, patients and users may be seriously injured.",
      "recall_initiation_date": "20181114",
      "center_classification_date": "20190108",
      "termination_date": "20210901",
      "report_date": "20190116",
      "code_info": "Serial Numbers: S403088, S403089, S403165",
      "more_code_info": ""
    }
  ]
}