Z-3052-2020 Class II Terminated

Recalled by ESAOTE S.P.A — Genova, N/A

Recall Details

Product Type
Devices
Report Date
October 7, 2020
Initiation Date
September 8, 2020
Termination Date
April 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 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)

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 K17510001