Home / Recalls / Medical Devices
ESAOTE S.P.A. recalls MyLab Ultrasound System; Models 6100, 6150, 6200, 6250; Probes: BL433, C 18, CA541, EC1123, EC123, IH 618, IOT332, IOT34
Recalled March 28, 2018 · FDA recall Z-1138-2018 · ESAOTE S.P.A
Hazard
The ultrasound system used in certain settings may result in overheating of the ultrasound probe head. · FDA Class II
Units
5
Sold at
US distribution in the states: AZ, FL, OK, PA, and TX.
Description
The ultrasound system used in certain settings may result in overheating of the ultrasound probe head.
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
Manufacturer(s)
ESAOTE S.P.A.
Made in
Italy
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →