Agency classClass IIOur severity:Severe FDA (Devices)·Z-3052-2020·Announced 2020-10-07

ESAOTE AC/DC Power Supply Recall for Portable Ultrasound Systems

ESAOTE is recalling AC/DC power adapters for specific portable ultrasound systems because the connector may heat up, smoke, or melt due to mechanical stress.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a risk of fire (smoke and melting) and is classified as FDA Class II, which aligns with the 'Severe' criteria for significant injury or property-damage reports.

Plain-English summary

ESAOTE S.P.A is recalling AC/DC power supply adapters (Part Number 151004300, XP Power Model Number AHM180PS19-XE0338) used with certain portable ultrasound diagnostic systems. The recall covers 989 adapters distributed nationwide in the United States. The affected ultrasound systems include the MyLabAlpha, MyLabGamma, MyLabOmega, MyLabSigma, MyLabSigma elite, MyLabAlphaVET, MyLabGammaVET, MyLabDelta, MyLabDeltaVET, MyLabOmegaVET, and MyLabSigmaVET models.

The recall is being conducted because the connector on the AC/DC adapter may heat up, generate smoke, and melt. This condition is caused by mechanical stress on the connection between the power adapter and the mains cable over time. The affected adapters have serial numbers below K17510001.

Users of these portable ultrasound systems should check the serial number of their AC/DC adapter. If the serial number is below K17510001, the adapter is part of this recall. Users should contact ESAOTE S.P.A for further instructions on how to resolve the issue.

The recalled product

Product: AC/DC POWER SUPPLY for 7400, Part Number 151004300, XP Power Model Number AHM180PS19-XE0338, AC/DC Adapter associated with the following portable ultrasound diagnostic systems: The AC/DC adapter is intended for use with the following portable ultrasound systems: MyLabAlpha…
Manufacturer: ESAOTE S.P.A
Category: Medical Device — Ultrasound Diagnostic Systems
Hazard: fire
burn-injury
Affected units: 989

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)

Serial Numbers: Below K17510001

Distribution

Distributed nationwide across the United 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

See all →

High
Esaote endocavity ultrasound probe recalled because liquid may leak in
FDA (Devices) · 2026-03-11
Severe
ESAOTE Portable Ultrasound AC/DC Power Supply Recall for Overheating Risk
FDA (Devices) · 2020-10-07
High
ESAOTE MyLab Gamma Ultrasound System Recalled for Probe Overheating Risk
FDA (Devices) · 2018-10-31
High
ESAOTE MyLab Seven Ultrasound System Recalled for Probe Overheating Risk
FDA (Devices) · 2018-10-31
High
ESAOTE MyLab Alpha Ultrasound System Recalled for Probe Overheating Risk
FDA (Devices) · 2018-10-31

Same hazard · fire