GE LOGIQ E10 Ultrasound System — Class II medical device recall Z-0588-2019
Terminated recall by GE Healthcare, LLC, reported 2018-12-19, distributed nationwide. There is a potential for an undetected over temperature condition on the trans-esophageal (TEE) probe leading
| Recall number | Z-0588-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2018-09-14 |
| Classified | 2018-12-07 |
| Reported by FDA | 2018-12-19 |
| Terminated | 2019-05-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, DK, FI, NO |
| Serial numbers | 00066US7, 500002US7, 500003US7, 500004US7, 500005US7, 500006US7, 500007US7, 500008US7, 500009US7, 500010US7, 500012US7, 500013US7, 500014US7, 500015US7, 500016US7, 500017US7, 500018US7, 500019US7, 500020US7, 500021US7, 500022US7, 500023US7, 500024US7, 500025US7, 500026US7 and 78 more |
| Model numbers | 530000E10 |
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 for recall
There is a potential for an undetected over temperature condition on the trans-esophageal (TEE) probe leading to a possible burn injury.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0588-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.