ESAOTE MyLab Ultrasound Systems Risk Overheating Probe Head

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Recalling firmESAOTE S.P.A.Sesto Fiorentino, Via Degli Olmi 11 · Sesto Fiorentino, N/A N/A

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✎ GovInfoNow plain-language explainer

What happened, in plain English

ESAOTE is recalling specific ultrasound systems that may overheat the probe head during use. This could cause damage to the device or affect medical imaging safety.

Why it’s dangerous

The ultrasound probe head may overheat when used in certain settings, potentially causing device damage or affecting imaging quality. This is not expected to cause serious injury or death in normal use.

Who’s affected

Healthcare providers using the MyLab ultrasound systems with the listed models and probe are affected. The risk is low for most users as overheating is unlikely to cause serious injury.

How to tell if you have this one

Check for the model numbers 6100, 6150, 6200, or 6250 on the ultrasound system and the PA023E 7.5/10 probe. The software version is between 4.0 and 13.60.

Brand
ESAOTE
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Model
Identify the ultrasound system model number (6100, 6150, 6200, or 6250) and probe type (PA023E 7.5/10).

✎ GovInfoNow

Questions people ask

Why is this recall happening?

The ultrasound system may overheat the probe head in certain settings, which could affect imaging quality or cause device damage.

Is there a fix for this issue?

The recall record does not mention a remedy or fix for the overheating issue.

How can I tell if my device is affected?

Check for the model numbers 6100, 6150, 6200, or 6250 on the ultrasound system and the PA023E 7.5/10 probe, with software versions 4.0 to 13.60.

Take action

Contact ESAOTE

We’ve drafted a message you can send ESAOTE to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-1137-2018 — ESAOTE ESAOTE

Hello,

I own a ESAOTE that is covered by recall Z-1137-2018 from ESAOTE.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1137-2018 (January 3, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1137-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

ESAOTE S.P.A. recalls MyLab Ultrasound System; Models 6100, 6150, 6200, 6250; PA023E Probe 7.5/10

Lower-risk recall