{ "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": "76987", "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 - USA (nationwide) Distribution and to the countries of : United Arab Emirates, Argentina, Armenia, Austria, Australia, Azerbaijan, Bahrain,Bangladesh, Belgium, Bolivia, Brazil, Canada, Chile, Columbia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, El Salvador, Ethiopia, Egypt, France, French Polynesia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Korea, Kuwait, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Myanmar, Netherlands, New Zealand, Norway, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, Venezuela, Vietnam and United Kingdom,", "recall_number": "Z-1875-2017", "product_description": "18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer \u0013 10041227 & 10789400 S1000 \u0013 10441701 S2000 \u0013 10041461 S2000 (Refurb) - 10440017 S3000 \u0013 10441730 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": "2,045 systems", "reason_for_recall": "When scanning with the 18L6 HD transducer on the ACUSON HELX\" Evolution with Touch Control, the ultrasound system may display a triple image or an image with a dark band. For the triple image issue, the system repeats one-third of the aperture, but does not display the full field of view.", "recall_initiation_date": "20170330", "center_classification_date": "20170424", "termination_date": "20190321", "report_date": "20170503", "code_info": "US serial numbers: 200113 200245 200394 200695 200706 200715 200935 201159 201256 201916 202076 202551 202559 202584 202587 202600 202626 202937 203212 205736 205850 206286 206919 206949 207048 207073 207087 207096 207099 207551 207552 207560 207566 207572 207648 207713 208114 208142 208153 208984 209481 210012 210017 210061 210128 210143 210157 210163 210173 210188 210241 210274 210324 210334 210439 210508 210569 210584 210664 210665 210666 210679 210703 210735 210737 210742 210744 210747 210753 210811 210832 210861 210873 210979 210981 211018 211026 211070 211093 211124 211138 211158 211167 211244 211249 211302 211316 211325 211335 211336 211337 211338 211340 211347 211352 211354 211355 211357 211362 211375 211460 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