{
  "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": "Malvern",
      "state": "PA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "69258",
      "recalling_firm": "Siemens Medical Solutions USA, Inc",
      "address_1": "51 Valley Stream Pkwy",
      "address_2": "N/A",
      "postal_code": "19355",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide Distribution - US including UT, MO, CO, MA, MN, MS, OH, SC, MI, and NY.",
      "recall_number": "Z-0004-2015",
      "product_description": "Siemens Uroskop Omnia Max system   The Uroskop Omnia is a solid state detector fluoroscopic X-Ray system, primarily for urological applications (functional x-ray diagnostic, endourology and minimal invasive urology/surgery). The system,, which includes a radiologic/urologic treatment table, may be used for urological, gastroenterological and gynecological treatment, planning and diagnostic procedures including but not limited to: \"Querying and retrieving patient history information and/or previous diagnosis and images from other modalities; \"X-ray examinations of the urogenital area \"Ultrasound examinations \"Endourological interventions \"Percutaneous interventions \"Laparoscopy \"Application of fistula \"Simple procedures \"Extracorporeal shock wave lithotripsy \"Uroflow/urodynamics \"Pediatric radiological and therapeutic applications",
      "product_quantity": "2",
      "reason_for_recall": "Two malfunctions posing potential risk to patients were identified with Siemens Ysio Max, AXIOM Luminos dRF Max, Uroskop Omnia Max, and Luminos Agile Max systems with a specific set of serial numbers that will cause lost images due to an automatic Radiology Information System (RIS) worklist update, thus causing examinations to be repeated. Image label may also be displayed incorrectly after images",
      "recall_initiation_date": "20140902",
      "center_classification_date": "20141002",
      "termination_date": "20150224",
      "report_date": "20141008",
      "code_info": "Siemens  Uroskop Omnia Max system, material #s: 10762473, serial numbers: 4014  4015"
    }
  ]
}