Agency classClass IIOur severity:High FDA (Devices)·Z-1138-2018·Announced 2018-03-28

ESAOTE MyLab Ultrasound Systems Recalled for Probe Overheating Risk

ESAOTE is recalling specific MyLab Ultrasound Systems because the probe head may overheat during use in certain settings.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (thermal injury) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

ESAOTE S.P.A. is recalling specific MyLab Ultrasound Systems, including models 6100, 6150, 6200, and 6250, due to a potential safety hazard. The recall involves five units distributed in Arizona, Florida, Oklahoma, Pennsylvania, and Texas. The affected systems utilize specific probe models, including BL433, C 18, CA541, EC1123, EC123, IH 618, IOT332, IOT342, L 415, LA332E, LA435, LA523, LA533, SI2C41, SL2325, and TRT33, and run software versions 12.10 through 13.60.

The recall is issued because the ultrasound system may result in the overheating of the ultrasound probe head when used in certain settings. This overheating presents a risk of thermal injury to patients or operators. No specific number of injuries or illnesses is reported in the source text.

Healthcare facilities and users should stop using the affected equipment immediately. They should contact ESAOTE S.P.A. for instructions on how to resolve the issue, which may involve software updates or equipment replacement.

The recalled product

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
Manufacturer: ESAOTE S.P.A.
Category: Medical Device — Diagnostic Imaging
Hazard: overheating
burn-injury
Affected units: 5

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

Software versions 12.10 - 13.60

Distribution

Distributed in 5 states:

Part of a larger recall action

This product is one of 2 recalled by ESAOTE S.P.A. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · ESAOTE S.P.A.

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Same hazard · overheating