ESAOTE S.P.A: Medical Device Recall in 2020 - (Recall #: Z-3053-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

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)

Product Classification:

Class II

Date Initiated: September 8, 2020

Date Posted: October 7, 2020

Recall Number: Z-3053-2020

Event ID: 86282

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.

Status: Terminated

Product Quantity: 989 total adapters in the US

Code Information:

Serial Numbers: Below K17350001

Distribution Pattern:

US Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated