GE LOGIQ E10 Ultrasound System, Model #530000E10. The device is intended for use by a qualified physician for ultrasound evaluation of Fetal/Obstetrics; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculoskeletal Conventional and Superficial; Urology (including prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (vascular).

Reason: There is a potential for an undetected over temperature condition on the trans-esophageal (TEE) probe leading to a possible burn injury.

Code information: Serial numbers 500055US7, 500103US7, 500022US7, 500059US7, 00066US7, 500083US7, 500057US7, 500130US7, 500114US7, 500105US7, 500111US7, 500039US7,500132US7, 500064US7, 500128US7, 500131US7, 500063US7, 500062US7, 500104US7, 500139US7, 500126US7, 500127US7, 500125US7, 500138US7, 500140US7, 500095US7, 500099US7, 500100US7, 500102US7, 500097US7, 500060US7, 500020US7, 500002US7, 500019US7, 500093US7, 500003US7, 500004US7,500005US7, 500065US7, 500072US7, 500058US7, 500049US7, 500050US7, 500047US7, 500035US7, 500021US7, 500023US7, 500024US7, 500025US7, 500026US7, 500007US7, 500008US7, 500009US7, 500010US7, 500013US7, 500014US7, 500016US7, 500017US7, 500012US7, 500029US7, 500043US7, 500061US7, 500006US7, 500015US7, 500085US7, 500080US7, 500042US7, 500070US7, 500030US7, 500122US7, 500082US7, 500135US7, 500121US7, 500086US7, 500027US7, 500048US7, 500053US7, 500054US7, 500056US7, 500116US7, 500038US7, 500045US7, 500036US7, 500051US7, 500073US7, 500076US7, 500079US7, 500084US7, 500091US7, 500034US7, 500077US7, 500133US7, 500087US7, 500134US7, 500074US7, 500068US7, 500037US7, 500018US7, 500069US7, 500067US7, 500071US7, 500044US7, and 500090US7.

Distribution pattern: Worldwide Distribution: US (nationwide) to states of: AZ, IL, MA, ME, MN, MT, PA, TX, and WA and countries of: Foreign distribution was made to Austria, Denmark, Finland, and Norway.