# FDA recall Z-1138-2018

> **ESAOTE S.P.A.** · Class II · device recall initiated 2018-01-03.

## Product

MyLab Ultrasound System; Models 6100, 6150, 6200, 6250; Probes: BL433, C 18, CA541, EC1123, EC123, IH 618, IOT332, IOT342, L 415, LA332E, LA435, LA523, LA533, SI2C41, SL2325, TRT33

## Reason for recall

The ultrasound system used in certain settings may result in overheating of the ultrasound probe head.

## Distribution

US distribution in the states: AZ, FL, OK, PA, and TX.

## Key facts

- **Recall number:** Z-1138-2018
- **Recalling firm:** ESAOTE S.P.A.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-01-03
- **Report date:** 2018-03-28
- **Termination date:** 2019-05-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Sesto Fiorentino, N/A, Italy

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1138-2018

## Citation

> AI Analytics. FDA recall Z-1138-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1138-2018. Source: US FDA. Licensed CC0.

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