{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "197023", "product_res_number": "Z-0754-2023", "event_date_initiated": "2022-11-10", "event_date_posted": "2022-12-22", "recall_status": "Open, Classified", "res_event_number": "91139", "product_code": "IYN", "product_description": "Vivid S5 N ultrasound. Not marketed in the US.\n\nUsed in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).", "code_info": "No US Distribution. 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P07089UL01, 07032ULT01, 09016UL01, P09010UL02, 10014ULT06, P72010UL04, P72010UL03, P72008UL05, P06008UL07, 11001ULT02, 14005ULT02, P16083UL01, 16027ULT06, P16075UL04, 16027ULT04, 16003ULT17, P16082UL01, P16087UL01, 16027ULT05, 16036ULT05, P16075UL05, P20012UL02, 20006ULT02, P20008UL21, P35077UL06, P20008UL20, P20008UL18, 20001ULT28, 20003ULT15, 21002ULT26, P21051UL01, 21002ULT31, P21054UL01, 22004ULT08, P23011UL11, 26001ULT17, 26001ULT18, 26001ULT20, P27023UL05, P27023UL11, P27029UL02, 27022ULT01, P28008UL05, P16021UL23, P34607UL01, 34094ULT15, P34485UL05, P34282UL15, 34094ULT14, P34594UL07, P34649UL01, P34282UL16, 34345ULT02, P34594UL06, 34034ULT29, P34552UL09, 34343ULT01, P34608UL07, P34616UL01, 34384ULT02, 34094ULT13, P34585UL01, 34009ULT31, 34433ULT12, P34540UL03, 34349ULT02, 34004ULT03, 34091ULT32, P34552UL11, 34225ULT04, 34315ULT06, P34282UL05, 34017ULT09, 34034ULT17, P34603UL01, 34395ULT04, P34282UL17, P34581UL01, 34078ULT19, 34803ULT03, P35095UL01, 35061ULT01, 35001ULT22, 35054ULT02, P35094UL01, 35004ULT14, P35104UL01, 35004ULT13, P41031UL06, P41031UL07, P33015UL09, P46012UL08, P46012UL07, 46003ULT17, 46003ULT12, 46003ULT13, P52009UL05, P52009UL04, P00028UL01, 39004ULT03, 39004ULT02, P41035UL02, P41042UL02, P41045UL01, P41045UL02, 41038ULT03, 41002ULT08, 42042ULT01, P42015UL05, P42015UL06, P43009UL06, P43009UL08, P43009UL09, P44033UL01, P45026UL01, 45001ULT09, P45033UL01, P45028UL01, P45030UL01, P47012UL03, P47012UL05, P47012UL04, P47016UL03, P33029UL03, 33037ULT03, 33022ULT04, P33036UL02, P48023UL03, 48017ULT03, P52027UL01, 54011ULT02, P54031UL01, 55025ULT04, 63011ULT13, 63009ULT05, P56005UL05, 57002ULT02, 59020ULT03, P59023UL01, 59033ULT01, P71003UL15, P63001UL16, P65005UL05, 60001ULT11, P34513UL12, P65022UL03, P65028UL02, P65028UL01, 77004ULT02, 77001ULT04, 66007ULT01, 67013ULT01, 67014ULT01, AE1526US02, AE1565US01, YE1191US01)", "firm_fei_number": "2126677", "recalling_firm": "GE Medical Systems, LLC", "address_1": "3000 N Grandview Blvd", "city": "Waukesha", "state": "WI", "postal_code": "53188-1615", "additional_info_contact": "GE Healthcare Service\n800-437-1171", "reason_for_recall": "Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire.", "root_cause_description": "Device Design", "action": "GE Healthcare notified consignees on about 11/10/2022 via letter titled \"URGENT MEDICAL DEVICE CORRECTION. For U.S. customers, letters were sent via FedEx. Consignees were instructed to follow updated safety instructions provided in the appendix included with the notification letter, place the appendix with the product labeling, and replace the batter every 2 years or if the battery is not capable of powering the system for more than 30 minutes. In response, GE Healthcare requested consignees return the response form.", "product_quantity": "1,400 units", "distribution_pattern": "Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV and the countries of Afghanistan, Albania, Algeria, Angola, Argentina, Armenia, Australia, Austria, AZERBAIJAN, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Burkina Faso, Cambodia, Cameroon, Canada, Chile, CHINA Colombia, CONGO, Costa Rica, Cote D'Ivoire, Croatia, Cyprus, CZECH REPUBLIC, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, Georgia, Germany, Ghana, Greece, Guatemala, Honduras, HONG KONG, Hungary, ICELAND, INDIA, Indonesia, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Korea (Republic of), Kosovo, Kuwait, KYRGYZSTAN, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, LUXEMBOURG, Macedonia, MALAYSIA, Mali, Mauritania, Mauritius, Mexico, MICRONESIA, Moldova, Morocco, Mozambique, Namibia, Nepal, Netherlands, NEW ZEALAND, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, SYRIA, TAIWAN, TANZANIA, THAILAND, Trinidad and Tobago, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Vietnam, Yemen.", "openfda": { "k_number": [ "K111582", "K180535", "K172342", "K003525", "K241582", "K121867", "K130308", "K914862", "K200449", "K110673", "K242523", "K182595", "K103152", "K160406", "K042770", "K092179", "K130881", "K200964", "K142714", "K242681", "K181985", "K103677", "K152052", "K162269", 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