{
  "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": "2026-04-01",
    "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": "86547",
      "recalling_firm": "Siemens Medical Solutions USA, Inc",
      "address_1": "40 Liberty Blvd",
      "address_2": "N/A",
      "postal_code": "19355",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide distribution.",
      "recall_number": "Z-0400-2021",
      "product_description": "ARTIS Icono Interventional Fluoroscopic X-Ray system - Product Usage: Intended Use: ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.",
      "product_quantity": "100 distributed worldwide. 31 distributed nationwide in U.S.",
      "reason_for_recall": "There is a software problem which affects the DSA Roadmap application on ARTIS Icono and ARTIS Pheno systems with software version VE20B. In rare cases, when the DSA acquisition has been started while the C-Arm or table is moving, there may be a shift between the image acquired at the start position and the image (i.e. DSA vessel map) taken at the reference position. This may lead to a DSA vessel map being overlaid to a subtracted fluoro image at a position that is not accurate.. However, if the displacement is slight or at an unfavorable plane, the user might rely on incorrect visualization of the catheter relative to the vessel map. This could imply danger to the patient.",
      "recall_initiation_date": "20200918",
      "center_classification_date": "20201104",
      "termination_date": "20210723",
      "report_date": "20201111",
      "code_info": "ARTIS Icono biplane - model # 11327600  ARTIS Icono Floor - model # 11327700    Serial numbers:  1) 170023  2) 170025  3) 170026  4) 170027  5) 180014  6) 180015  7) 180018  8) 180019  9) 180021  10) 180029  11) 180034  12) 180035  13) 180037  14) 180040  15) 180041  16) 180043  17) 180046  18) 180047  19) 180048  20) 180049  21) 180053  22) 180054  23) 180055  24) 180057  25) 180060  26) 180062  27) 180065  28) 180066  29) 180067  30) 180068  31) 180070  ***Updated 11/6/2020***  180072"
    }
  ]
}