{
  "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": "87683",
      "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-1496-2021",
      "product_description": "Artis systems - Product Usage: an angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.  Model Numbers:  System\t                Material #  AXIOM Artis FC\t05904433;  AXIOM Artis FA\t05904441;  AXIOM Artis MP\t05904466;  AXIOM Artis BC\t05904649;  AXIOM Artis BA\t05904656;  AXIOM Artis dBC Mag. Nav.\t05917054;  AXIOM Artis TA\t07007755;  AXIOM Artis dTA\t07008605;  AXIOM Artis dFC\t07412807;  AXIOM Artis dTC\t07413078;  AXIOM Artis dBA\t07555357;  AXIOM Artis dMP\t07555365;  AXIOM Artis dFA\t07555373;  AXIOM Artis dFC Mag. Nav.\t07727717;  AXIOM Artis TC\t07728350;  AXIOM Artis dBC\t07728392;  Artis zee floor\t        10094135;  Artis zee ceiling\t10094137;  Artis zee MP\t        10094139;  Artis zee biplane\t10094141;  Artis zee floor MN\t10094142;  Artis zee biplane MN 10094143;  Artis Q floor\t        10848280;  Artis Q ceiling\t        10848281;  Artis Q biplane  \t10848282;  Artis Q.zen floor\t10848353;  Artis Q.zen ceiling\t10848354;  Artis Q.zen biplane\t10848355.",
      "product_quantity": "3,320 units U.S.",
      "reason_for_recall": "Due to inappropriate cleaning, some Artis systems show unexpected corrosion of visible belts which are needed to move system parts (e.g. C-Arm), Increased corrosion may lead to a malfunction of the belts which may result in limited functionality of the Artis system up to system failure. Unintended movement of the C-Arm may cause a hazardous situation to the patient, operator, or staff members and may result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system",
      "recall_initiation_date": "20210330",
      "center_classification_date": "20210426",
      "termination_date": "20220712",
      "report_date": "20210505",
      "code_info": "All serial numbers",
      "more_code_info": ""
    }
  ]
}