MyLab Ultrasound System recalled over fire hazard
- Recall date
- January 3, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- ESAOTE S.P.A. recalls MyLab Ultrasound System; Models 6100, 6150, 6200, 6250; Probes: BL433, C 18, CA541, EC1123, EC123, IH 618, IOT332, IOT3…
- Recall number
- Z-1138-2018
- FDA classification
- Class II
- Brand / firm
- ESAOTE S.P.A.
- Sold / distributed
- US distribution in the states: AZ, FL, OK, PA, and TX.
Why it was recalled
The ultrasound system used in certain settings may result in overheating of the ultrasound probe head.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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
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