Z-0588-2019Class II

GE LOGIQ E10 Ultrasound System, Model #530000E10. The device is intended for use by a qualified physician for...

Name: Z-0588-2019 GE LOGIQ E10 Ultrasound System, Model #530000E10. The device is intended for use by a qualified physician for...
Creator: GE Healthcare, LLC
Published: 2018-09-14
License: https://open.fda.gov/license/

GE Healthcare / initiated 2018-09-14 / Terminated

FDA source

GE Healthcare, LLC began a recall of GE LOGIQ E10 Ultrasound System, Model #530000E10. The device is intended for use by a qualified physician for ultrasound evaluation of Fetal/Obstetrics... on 2018-09-14. FDA classified it as Class II and gives the reason as "There is a potential for an undetected over temperature condition on the trans-esophageal (TEE) probe leading to a possible burn injury". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0588-2019
Classification: Class II
Status: Terminated
Initiated: 2018-09-14
Posted: 2018-12-07
Terminated: 2019-05-29
Recalling firm: GE Healthcare
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).
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
Reason for recall: There is a potential for an undetected over temperature condition on the trans-esophageal (TEE) probe leading to a possible burn injury.
FDA 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 in commerce: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0588-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0588-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-19	2018-12-07

Product code IYN

K173555Class IILogiq E10GE Healthcare / cleared 2017-12-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)