CLASS II Device recall · Reported 31 Oct 2018 · FDA Enforcement Report
MyLab Seven recalled by Esaote S.p.a
Esaote S.p.a 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
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 S.p.a, 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 AlaskaArizonaCaliforniaIndianaMissouriNew MexicoPennsylvaniaSouth CarolinaTexas
Questions about this recall
Is MyLab Seven recalled?
Yes. Esaote S.p.a recalled MyLab Seven on 11 Jun 2018. The recall is Class II and its status is Terminated. Recall number Z-0206-2019.
Why was it recalled?
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.
Which lots are affected?
n/a
Where was it sold?
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.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Esaote S.p.a
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|---|---|---|---|---|---|
| Device | CLASS II | Endocavity ultrasonic probe recalled by Esaote S.p.a | Esaote S.p.a | Packaging Defects | Nationwide |
| Device | CLASS II | AC/DC Power Supply recalled by Esaote S.p.a | Esaote S.p.a | Other | Nationwide |
| Device | CLASS II | AC/DC Power Supply recalled by Esaote S.p.a | Esaote S.p.a | Other | Nationwide |
| Device | CLASS II | MyLab Alpha recalled by Esaote S.p.a | Esaote S.p.a | Device Malfunction | Nationwide |
| Device | CLASS II | MyLab Gamma recalled by Esaote S.p.a | Esaote S.p.a | Device Malfunction | Nationwide |
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