CLASS II Device recall · Reported 7 Oct 2020 · FDA Enforcement Report
AC/DC Power Supply recalled by Esaote S.p.a
Esaote is recalling AC/DC Power Supply for 7400, distributed nationwide in the US. The recall was initiated on 8 Sep 2020 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-3052-2020
- FDA event ID
- 86282
- Recalling firm
- Esaote, Genova, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Sep 2020
- FDA classified
- 30 Sep 2020
- Reported
- 7 Oct 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 8 Sep 2020 | Recall initiated by company | |
| 30 Sep 2020 | Classified by FDA | +22 days |
| 7 Oct 2020 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The AC/DC adapter (power supply) of the portable ultrasound systems listed below that may result in the connector heating up, generating smoke and melting. This condition is caused by the mechanical stress of the connection between the AC/DC power adapter and the mains cable over the time of use.
Product as listed by the FDA
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 (101740000) MyLabGamma (101741000) MyLabOmega (101740004) MyLabSigma (101741004) MyLabSigma elite (101741007) MyLabAlphaVET (101740001) MyLabGammaVET (101741001) MyLabDelta (100743000) MyLabDeltaVET (100743001) MyLabOmegaVET (101740005) MyLabSigmaVET (101741005)
Where it was distributed
US Nationwide
Questions about this recall
Why was it recalled?
The AC/DC adapter (power supply) of the portable ultrasound systems listed below that may result in the connector heating up, generating smoke and melting. This condition is caused by the mechanical stress of the connection between the AC/DC power adapter and the mains cable over the time of use.
Which lots are affected?
Serial Numbers: Below K17510001
Where was it sold?
US Nationwide
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
1 other product · FDA event 86282This product is part of a recall event; the main page for the event is AC/DC Power Supply recalled by Esaote S.p.a.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | AC/DC Power Supply recalled by Esaote S.p.a | Esaote | Other | Nationwide |
More recalls from Esaote
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Endocavity ultrasonic probe recalled by Esaote S.p.a | Esaote | Packaging Defects | Nationwide |
| Device | CLASS II | AC/DC Power Supply recalled by Esaote S.p.a | Esaote | Other | Nationwide |
| Device | CLASS II | MyLab Seven recalled by Esaote S.p.a | Esaote | Device Malfunction | Nationwide |
| Device | CLASS II | MyLab Alpha recalled by Esaote S.p.a | Esaote | Device Malfunction | Nationwide |
| Device | CLASS II | MyLab Gamma recalled by Esaote S.p.a | Esaote | Device Malfunction | Nationwide |
Other Imaging Equipment recalls
All 2,347| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |