Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

MyLab Ultrasound System Recalled by ESAOTE S.P.A. Due to The ultrasound system used in certain settings may...

Date: January 3, 2018
Company: ESAOTE S.P.A.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact ESAOTE S.P.A. directly.

Affected Products

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

Quantity: 5

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed to 5 states: AZ, FL, OK, PA, TX

Affected (5 states)Not affected

About ESAOTE S.P.A.

ESAOTE S.P.A. has 6 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report