{ "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": "Mountain View", "state": "CA", "country": "United States", "classification": "Class II", "openfda": {}, "product_type": "Devices", "event_id": "71687", "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 - Nationwide Distribution including Puerto Rico and to the countries of : Algeria, Angola, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia Herzeg., Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Cyprus, Czech Republic, Dem. Rep. Congo, Denmark, Dominican Rep., Ecuador, Egypt, El Salvador, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Lebanon, Malaysia, Mexico, Morocco, Nepal, Netherlands, New Zealand, Norway, P.R. China, Peru, Philippines, Poland, Portugal, Republic Korea, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad,Tobago, Turkey, Turkmenistan, U.A.E., Ukraine, United Kingdom, Uzbekistan, Venezuela and Vietnam.", "recall_number": "Z-2314-2015", "product_description": "ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017 \u0013 S 2000 system 10441730 \u0013 S 3000 system 10441701 \u0013 S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.", "product_quantity": "1789 units", "reason_for_recall": "Potential measurement error on ACUSON S Family ultrasound system when using the Doppler manual trace measurement tool in full screen format that has a low probability of misdiagnosis.", "recall_initiation_date": "20150625", "center_classification_date": "20150729", "termination_date": "20171019", "report_date": "20150805", "code_info": "Model numbers: 10041461, 10440017 \u0013 S2000 system 10441730 \u0013 S3000 system 10441701 \u0013 S1000 system; software version VC30A, VC30B, VC30C, or VC31A; Serial numbers US: 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