# FDA recall Z-0588-2019

> **GE Healthcare, LLC** · Class II · device recall initiated 2018-09-14.

## 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.

## 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.

## Key facts

- **Recall number:** Z-0588-2019
- **Recalling firm:** GE Healthcare, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-09-14
- **Report date:** 2018-12-19
- **Termination date:** 2019-05-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Waukesha, WI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0588-2019

## Citation

> AI Analytics. FDA recall Z-0588-2019. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0588-2019. Source: US FDA. Licensed CC0.

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