GE Healthcare, LLC: 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).

Recall number

Z-0588-2019

Recalling firm

GE Healthcare, LLC

Product

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).

Status

Terminated

Initiated

2018-09-14

Posted

not on file

Terminated

2019-05-29

Reason

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

Root cause

Process change control

Action

The recalling firm, GE Healthcare, issued an "URGENT MEDICAL DEVICE CORRECTION" letter dated 9/14/2018 via traceable means to each of their customer locations. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: Do not use a TEE probe (GE model 6Tc-RS) from another device on the LOGIQ E10 system until your LOGIQ E10 is corrected. You may scan normally with any other probes. GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for the correction. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

Quantity

103 devices(64 US; 39 OUS)

Distribution

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.

Lot, serial or model codes

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.

510(k) numbers

K173555

PMA numbers

not on file

Product code

IYN

Firm FEI

2126677

Firm city

Waukesha

Firm state

WI

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 3e6df46828c1, published 2026-10-06

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