Z-3053-2020 Class II Terminated
FDA device recall Z-3053-2020 was initiated by ESAOTE S.P.A on Sep 8, 2020 and is designated Class II. 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… The recall status is terminated (terminated Apr 17, 2023). Affected quantity: 989 total adapters in the US.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 7, 2020
- Initiation Date
- Sep 8, 2020
- Termination Date
- Apr 17, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 989 total adapters in the US
Product Description
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 (101740000) MyLabGamma (101741000) MyLabOmega (101740004) MyLabSigma (101741004) MyLabSigma elite (101741007) MyLabAlphaVET (101740001) MyLabGammaVET (101741001) MyLabDelta (100743000) MyLabDeltaVET (100743001) MyLabOmegaVET (101740005) MyLabSigmaVET (101741005)
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.
Distribution Pattern
US Nationwide
Code Information
Serial Numbers: Below K17350001
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-3053-2020
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026