FDA-Device2018-03-28Class II
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
ESAOTE S.P.A.
Hazard
The ultrasound system used in certain settings may result in overheating of the ultrasound probe head.
Sold states
US distribution in the states: AZ, FL, OK, PA, and TX.
Affected count
5
Manufactured in
Sesto Fiorentino, Via Degli Olmi 11, Sesto Fiorentino, N/A, Italy
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1138-2018Don't want to check this manually?
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