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FDA (Device enforcement)Recalled 2022-11-10class ii

GE Medical Systems, LLC: Vivid S5 Ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cep

Hazard

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.

Details from the source

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. Distribution: 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, Bahrai Quantity: 5,649 units Lot/code info: Model Number (System ID): H45021LC (VS50873, VS51169, VS5227, VS594, VS5289, VS544, VS5155, VS50058, VS519, VS551, VS50589, VS5286, VS5317, VS5299, VS50954, VS50940, VS560, VS50793, VS50311, VS50028, VS5125, VS50648, VS50721, VS50851, VS5300, VS5224, VS516, VS5306, VS50097, VS50154, VS50841, VS50513, VS5294, VS5151, VS50908, VS5511, VS5169, VS50746, VS50795, VS50816, VS50895, VS51008, VS50750, VS5304, VS5297, VS5495, VS50634, VS5874, VS50830, VS50931, DZ1270US01, AZ4001US03, AZ4002US01, 130083US09, 629782US01, 220909US02, 190282US07, 190282US08, 030232US18, 030232US19, 030151US07, 030151US06, 030151US05, 624025US01, 030488US01, 190226US06, 852578US02, 110009US05, 190902US02, 550020US03, 030024US01, 100029US06, 110014US31, 110014US06, 030800US16, 110019US17, VS5146VS5, VS50530VS5, VS5194VS5, VS5133VS5, VS5147VS5, VS5545VS5, 2830213, LP594207SU8, VS5176VS5, VS50166VS5, BG4607US01, BG4576US01, BG4037US08, BG4000US03, 519631VS5A, VS5907VS5, 2829006, 082438090140, 082438070046, 082438070047, 082438070048, 082438070049, 082438160195, 082438090155, 082438220037, 082438030051, 082438070167, 082438090130, 082438160116, 082438300015, 082438070077, 082438110042, 082438210055, 082438070057, 082438070058, 082438070059, 082438070060, 082438070061, 082438070062, 082438100143, 082438030053, 082438110052, 082438160151, 082438100141, 082438130066, 082438130068, 082438130073, 082438050028, 082438110051, 082438210045, 082438090159, 082438100142, 082438080029, 082438090156, 082438090167, VS50488V

UPC codes

082438090140, 082438070046, 082438070047, 082438070048, 082438070049, 082438160195, 082438090155, 082438220037, 082438030051, 082438070167, 082438090130, 082438160116, 082438300015, 082438070077, 082438110042, 082438210055, 082438070057, 082438070058, 082438070059, 082438070060, 082438070061, 082438070062, 082438100143, 082438030053, 082438110052, 082438160151, 082438100141, 082438130066, 082438130068, 082438130073, 082438050028, 082438110051, 082438210045, 082438090159, 082438100142, 082438080029, 082438090156, 082438090167, 082438040173, 082438230101

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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