CLASS II Device recall · Reported 31 Oct 2018 · FDA Enforcement Report

MyLab Seven recalled by Esaote S.p.a

Esaote is recalling MyLab Seven, distributed nationwide in the US. The recall was initiated on 11 Jun 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesn/a

Quantity recalled10

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0206-2019
FDA event ID: 81285
Recalling firm: Esaote, Sesto Fiorentino, N/A
Classification: Class II
Status: Terminated
Recall initiated: 11 Jun 2018
FDA classified: 23 Oct 2018
Reported: 31 Oct 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

11 Jun 2018	Recall initiated by company
23 Oct 2018	Classified by FDA	+134 days
31 Oct 2018	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The probe power monitoring settings have been found to be not appropriate under specific operating conditions when connected to the devices listed below. This issue may result in overheating of the probe head. The probe power monitoring settings may not be effective in specific operating conditions so that the surface of the probe head may overheat in around one minute of continuous operations. The patient may experience discomfort, reddening of epidermis and/or mild pain. To date, no patient injury has been reported with regards to this issue.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

MyLab Seven, Model 6400

Where it was distributed

Worldwide distribution - US Nationwide in the states of AK, AZ, CA, IN, MO, NM, PA, SC, and TX. and countries Argentina and Australia Austria Bangladesh Belgium Brazil Bulgaria China Costa Rica Denmark Egypt Finland France Germany Greece Hong Kong Hungary Iceland India Iran Italy Japan Kuwait Mexico Netherlands Norway Paraguay Poland Portugal Russian Fed. Saudi Arabia Singapore Slovenia South Africa South Korea Spain Switzerland Taiwan Thailand Tunisia Turkey United Kingdom Utd.Arab Emir.

Nationwide Alaska Arizona California Indiana Missouri New Mexico Pennsylvania South Carolina Texas

Questions about this recall

Why was it recalled?

Which lots are affected?

n/a

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 81285

This product is part of a recall event; the main page for the event is MyLab Gamma recalled by Esaote S.p.a.

Reported	Class	Recall	Company	Reason	Where
31 Oct 2018	CLASS II	MyLab Gamma recalled by Esaote S.p.a	Esaote	Device Malfunction	Nationwide
31 Oct 2018	CLASS II	MyLab Alpha recalled by Esaote S.p.a	Esaote	Device Malfunction	Nationwide

More recalls from Esaote

All 9

Reported	Class	Recall	Company	Reason	Where
11 Mar 2026Device	CLASS II	Endocavity ultrasonic probe recalled by Esaote S.p.a	Esaote	Packaging Defects	Nationwide
7 Oct 2020Device	CLASS II	AC/DC Power Supply recalled by Esaote S.p.a	Esaote	Other	Nationwide
7 Oct 2020Device	CLASS II	AC/DC Power Supply recalled by Esaote S.p.a	Esaote	Other	Nationwide
31 Oct 2018Device	CLASS II	MyLab Alpha recalled by Esaote S.p.a	Esaote	Device Malfunction	Nationwide
31 Oct 2018Device	CLASS II	MyLab Gamma recalled by Esaote S.p.a	Esaote	Device Malfunction	Nationwide

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