{ "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": "2026-08-27", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "191763", "product_res_number": "Z-0748-2022", "event_date_initiated": "2022-01-19", "event_date_created": "2022-03-11", "recall_status": "Open, Classified", "res_event_number": "89499", "product_code": "IYN", "k_numbers": [ "K201130" ], "product_description": "Diagnostic Ultrasound System, ACUSON Juniper, UDI: (01)04056869152059, Model: 11335791, Rx, CE \n\nUltrasound imaging system intended for the following applications: Vascular, Abdominal, Neonatal, Echocardiographical, Pediatric, Small Parts, Musculoskeletal, Obstetrical, Gyneological, Intraoperative, and Urological applications using different ultrasound transducers for different applications.", "code_info": "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": "425-392-9180", "reason_for_recall": "The clip store function in the ultrasound imaging system does not work when the system has a disk full error. This could cause a delay in treatment if the ultrasound system is unable to save clips as study documentation during a high risk procedure, such as a stress echo exam.", "root_cause_description": "Software design", "action": "The firm, Siemens Healthineers, sent \"URGENT MEDICAL DEVICE SAFETY CORRECTION\" Letters Juniper 1.0 (VA10D/VA10E/VA10F) to affected customers via Siemens update program US026/21/S informing them of the issue and advising them the firm will correct this issue with a free-of-charge software update to their ACUSON Juniper ultrasound system. The customers were instructed to do the following: Check the available storage on the ultrasound system prior to starting a study where clips are vital to the \ndocumentation, such as stress echo. If available, use a different ultrasound system capable of performing a stress echo exam until the problem is resolved. If another ultrasound system is not available, consider using other imaging modalities to achieve the diagnostic outcome. In the event that a defect is encountered, a reinstallation of the system software can resolve this problem until the available storage on the ultrasound system is again exceeded.\n\nThe customers' respective customer service engineer will contact them to schedule a facility visit to update the system or inform them of a remote update.\n\nIf you have further questions regarding this safety correction, please send all inquiries to: Siemens Healthineers USD Complaints usd-complaint.team@siemens-healthineers.com.", "product_quantity": "2846", "distribution_pattern": "Worldwide distribution: US (nationwide) and countries of: Algeria, Andorra, Argentina, Australia, Austria, Bangladesh, Belgium, Bosnia Herzeg, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Faroe Islands, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Kazakhstan, Kosovo, Kuwait, Latvia, Liechtenstein, Lithuania, Luxembourg, Malaysia, Mexico, Morocco, Myanmar, Namibia, Netherlands, New Zealand, Norway, Oman, Peru, Philippines, Poland, Portugal, Qatar, Rep. of Yemen, Republic Korea, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sudan, Sweden, Switzerland, Taiwan, Thailand, Turkey, U.A.E., Ukraine, United Kingdom, Uruguay, Vietnam, and Zimbabwe.", "openfda": { "k_number": [ "K233788", "K062247", "K133329", "K211886", "K182715", "K050326", "K033311", "K934915", "K251322", "K083095", "K103397", "K023996", "K882755", "K182603", "K233597", "K934041", "K221496", "K192030", "K112953", "K220269", "K141462", "K152052", "K142160", "K102390", "K152962", "K083114", "K182636", "K103152", "K201971", "K250024", "K170823", "K220169", "K140834", "K020630", "K981397", "K113613", "K131267", "K141010", "K250026", "K251110", "K032974", "K122114", "K130308", "K210713", "K053435", "K171926", "K132274", "K252433", "K242594", "K994369", "K052894", "K242005", 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