The Recall Desk

FDA (Devices) recall action 86282

ESAOTE S.P.A recalled 2 products on 2020-10-07

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2020-10-07
Critical
0
Units
1,978

Why these products were 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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • SevereFDA (Devices)··2020-10-07

    ESAOTE AC/DC Power Supply Recall for Portable Ultrasound Systems

    ESAOTE is recalling AC/DC power adapters for specific portable ultrasound systems because the connector may heat up, smoke, or melt due to mechanical stress.

    Product
    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 (1017
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2020-10-07

    ESAOTE Portable Ultrasound AC/DC Power Supply Recall for Overheating Risk

    ESAOTE is recalling AC/DC power supplies for specific portable ultrasound systems because the connector may heat up, generate smoke, and melt.

    Product
    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 (1017
    Category
    Distribution
    0 states