Agency classClass IIOur severity:Severe FDA (Devices)·Z-3053-2020·Announced 2020-10-07

ESAOTE Portable Ultrasound AC/DC Power Supply Recall for Overheating Risk

ESAOTE is recalling AC/DC power supplies for specific portable ultrasound systems because the connector may heat up, generate smoke, and melt.

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 fire and burn hazard (heating, smoke, melting) for a medical device, which aligns with the 'Severe' criteria for significant injury or property damage risks.

Plain-English summary

ESAOTE S.P.A is recalling AC/DC power supplies (Part Number 151004301, XP Power Model Number AHM180PS19-XE1057) used with specific portable ultrasound diagnostic systems. The affected systems include the MyLabAlpha, MyLabGamma, MyLabOmega, MyLabSigma, MyLabSigma elite, MyLabAlphaVET, MyLabGammaVET, MyLabDelta, MyLabDeltaVET, MyLabOmegaVET, and MyLabSigmaVET models.

The recall is due to a condition where the connector may heat up, generate smoke, and melt. This issue is caused by mechanical stress on the connection between the AC/DC power adapter and the mains cable over time. There are 989 total adapters in the US, distributed nationwide. The affected serial numbers are below K17350001.

Consumers should stop using the affected AC/DC adapters and contact ESAOTE S.P.A for further instructions on replacement or repair.

The recalled product

Product: AC/DC POWER SUPPLY for 7400, Part Number 151004301, XP Power Model Number AHM180PS19-XE1057, 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 K17350001

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 →

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ESAOTE AC/DC Power Supply Recall for Portable Ultrasound Systems
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ESAOTE MyLab Seven Ultrasound System Recalled for Probe Overheating Risk
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ESAOTE MyLab Alpha Ultrasound System Recalled for Probe Overheating Risk
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Same hazard · fire