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ESAOTE S.P.A. recalls MyLab Ultrasound System; Models 6100, 6150, 6200, 6250; PA023E Probe 7.5/10
Recalled March 28, 2018 · FDA recall Z-1137-2018 · 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
1
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; PA023E Probe 7.5/10
Manufacturer(s)
ESAOTE S.P.A.
Made in
Italy
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →