{
  "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": "2026-04-22",
    "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": "70020",
      "recalling_firm": "Siemens Medical Solutions USA, Inc",
      "address_1": "51 Valley Stream Pkwy",
      "address_2": "N/A",
      "postal_code": "19355-1406",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Distribution to states of: ID, IL, MI, MN, MO, ND and PA.",
      "recall_number": "Z-0994-2015",
      "product_description": "Ysio Max, Luminos dRF Max and Agile Max systems with software version VE10 and SmartOrtho license.    The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma, critical ill) applications. Exposures may be taken with the patient sitting, standing, or in the prone position. The Ysio Max system is not meant for mammography. The Ysio Max uses integrated or portable digital detectors for generating diagnostic images by converting    x-rays into electronic signals. Ysio Max is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes.",
      "product_quantity": "11",
      "reason_for_recall": "Potential for composed images to be flipped  before being sent to PACS on systems with software version VE10 and SmartOrtho license. Flipped images may be reversed so the associated annotations, e.g. labels (R/L), may be displayed incorrectly, potentially leading to misdiagnosis.",
      "recall_initiation_date": "20141215",
      "center_classification_date": "20150116",
      "termination_date": "20170126",
      "report_date": "20150128",
      "code_info": "Material  10762470  10762470  10762470  10762470  10762470  10762470  10762470  10762470  10762470  10762470  10762470   serial numbers24077  24051  24038  24059  24066  24015  24026  24058  24039  24090  24075"
    }
  ]
}