The Recall Desk

FDA (Devices) recall action 79547

ESAOTE S.P.A. recalled 2 products on 2018-03-28

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
2018-03-28
Critical
0
Units
6

Why these products were recalled

The ultrasound system used in certain settings may result in overheating of the ultrasound probe head.

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.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2018-03-28

    ESAOTE MyLab Ultrasound Systems Recalled for Probe Overheating Risk

    ESAOTE is recalling specific MyLab Ultrasound Systems because the probe head may overheat during use in certain settings.

    Product
    MyLab Ultrasound System; Models 6100, 6150, 6200, 6250; Probes: BL433, C 18, CA541, EC1123, EC123, IH 618, IOT332, IOT342, L 415, LA332E, LA435, LA523, LA533, SI2C41, SL2325, TRT33
    Category
    Distribution
    5 states