{ "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": "2026-09-10", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "190620", "product_res_number": "Z-0547-2022", "event_date_initiated": "2021-11-12", "event_date_created": "2022-02-03", "recall_status": "Open, Classified", "res_event_number": "89139", "product_code": "IYN", "k_numbers": [ "K201462" ], "product_description": "ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B", "code_info": "Software Version VA25A/B\n\nSystem Serial 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"firm_fei_number": "3023245", "recalling_firm": "Siemens Medical Solutions USA, Inc.", "address_1": "22010 SE 51st St", "city": "Issaquah", "state": "WA", "postal_code": "98029-7298", "additional_info_contact": "Siemens Healthineers USD Complaints\n425-392-9180", "reason_for_recall": "Due to a calculation error in the measurement when using 2D trace (manual trace) tool. The trace circumference value is overestimated and may potentially result in misdiagnosis of a patient's condition.", "root_cause_description": "Software design", "action": "On 11/12/2021, the firm sent a \"MEDICAL DEVICE SAFETY CORRECTION\" Letter via email and certified US Post to inform customers that within their ultrasound system there is a calibration error in the measurement when using the 2D trace (manual trace) tool. the trace circumference value is overestimated, however, the area value is accurate.\n\nCustomers are instructed:\n-To avoid overestimation of circumference measurements, use the default ellipse tool for all circumference measurements.\n-To avoid overestimation of distance measurements, use default distance tool for all distance measurements.\n\nThe Recalling Firm will correct this issue with a free-of-charge update to affected ultrasound systems with a new software version. Customer will be contacted by a service engineer to schedule a facility visit to update the system or inform them of a remote update.\n\nFor questions, send any inquires to:\nSiemens Healthineers USD Complaints at usd-complaint.team@siemens-healthineers.com", "product_quantity": "1161 systems", "distribution_pattern": "Worldwide distribution - U.S. Nationwide distribution in the states of AL, AK, AZ, AR, CA, CO, CN, DE, FL, GA, HI, IL, IN, IA, KS, KY, LA, MD, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, WA, WV, WI, and WY. The countries of United Arab Emirates, Armenia, Angola, Austria, Australia, Azerbaijan, Bangladesh, Belgium, Bahrain, Brazil, Switzerland, Chile, China, Colombia, Cyprus, Czech Republic, Germany, Denmark, Dominican Rep., Egypt, Spain, Finland, France, United Kingdom, Georgia, Greece, Guatemala, Hong Kong, Croatia, Indonesia, Israel, Iceland, Italy, Japan, Republic Korea, Kuwait, Lithuania, Luxembourg, Mexico, Netherlands, New Zealand, Poland, Portugal, Qatar, Romania, Serbia, Russian Fed., Saudi Arabia, Sweden, Singapore, Slovakia, Thailand, Turkey, Taiwan, Ukraine, South Africa.", "openfda": { "k_number": [ "K250543", "K260595", "K170521", "K954220", "K060542", "K073709", "K052331", "K163082", "K190989", "K034003", "K120321", "K112646", "K241979", "K251651", "K141369", "K203657", "K213487", "K990360", "K123503", "K152309", "K202455", "K011457", "K202406", "K223017", "K954022", "K143264", "K010405", "K840402", "K191922", "K000931", "K161843", "K222754", "K010631", "K112339", "K160381", 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