FDA Device recall Z-0588-2019
GE LOGIQ E10 Ultrasound System, Model #530000E10
- FDA Device
- Class II
- terminated
- Published 2018-12-19
On 2018-12-19 the FDA classified a Class II recall of GE LOGIQ E10 Ultrasound System, Model #530000E10 by Ge Healthcare, citing there is a potential for an undetected over temperature condition on the trans-esophageal (TEE) probe leading to a possible burn injury.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0588-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-09-14 |
| Published | 2018-12-19 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ge Healthcare |
| Distribution | US |
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).
Reason
There is a potential for an undetected over temperature condition on the trans-esophageal (TEE) probe leading to a possible burn injury.
Identifiers
| code_info | Serial numbers 500055US7, 500103US7, 500022US7, 500059US7, 00066US7, 500083US7, 500057US7, 500130US7, 500114US7, 500105…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, 500034US |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0588-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.