{
  "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": "Mountain View",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "71116",
      "recalling_firm": "Siemens Medical Solutions USA, Inc.",
      "address_1": "685 E Middlefield Rd",
      "address_2": "N/A",
      "postal_code": "94043-4045",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution -  US Nationwide and the countries of:Angola, Armenia, Australia, Austria, Belgium, Bosnia Herzeg., Brazil, Brunei, Bulgaria, Colombia, Czech Republic, Finland, France, Germany, India, Japan, Kazakhstan, Kenya, Kuwait, Mauritius, Mexico, Norway, Oman, P.R. China, Poland, Rep. of Yemen, Republic Korea, Romania, Russian Fed., Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, U.A.E., United Kingdom.",
      "recall_number": "Z-1581-2015",
      "product_description": "ACUSON SC2000 volume imaging ultrasound systems at software versions VA16C, VA16D and VA16E. Model 10433816.    Product Usage:  The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraoperative Neurological, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. Typical examination performed using the SC2000 Ultrasound System are: Cardiac Imaging Applications and Analysis; Vascular Imaging Applications and Analysis; Superficial Imaging Applications; Intraoperative Imaging Applications; Transcranial Imaging Applications;",
      "product_quantity": "186 devices",
      "reason_for_recall": "In some cases, the system is unable to capture a clip or image during a routine scan.",
      "recall_initiation_date": "20120511",
      "center_classification_date": "20150505",
      "termination_date": "20150506",
      "report_date": "20150513",
      "code_info": "Model 10433816, software versions VA16C, VA16D and VA16E.  Device serial numbers:   400230  400708  400462  400467  400460  400461  400084  451021  400743  400225  450122  400634  400687  400023  400126  400265  400717  400740  400458  400459  400678  400665  450123  400617  400485  400083  400092  451024  400223  400404  450143  400650  400663  400664  400577  400470  400479  400493  400519  400318  400674  400463  400484  400679  400680  400589  400466  400168  400139  400270  400308  400236  400689  400691  450151  400693  400615."
    }
  ]
}