FDAJanuary 3, 2018device
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 recall recorded by the U.S. Food & Drug Administration.
The hazard
The ultrasound system used in certain settings may result in overheating of the ultrasound probe head.
What to do
FDA enforcement status: Terminated
Brands named
esaote s p aesaote
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAEsaote Endocavity ultrasonic probe, Model E 3-12, REF 1200000382025-03-14
- FDAAC/DC POWER SUPPLY for 7400, Part Number 151004300, XP Power Model Number AHM180PS19-XE0338, AC/DC Adapter associated with the following portable ultrasound diagnostic systems: The AC/DC adapter is intended for use with the following portable ultrasound systems: MyLabAlpha (101740000) MyLabGamma ...2020-09-08
- FDAAC/DC POWER SUPPLY for 7400, Part Number 151004301, XP Power Model Number AHM180PS19-XE1057, AC/DC Adapter associated with the following portable ultrasound diagnostic systems: The AC/DC adapter is intended for use with the following portable ultrasound systems: MyLabAlpha (101740000) MyLabGamma ...2020-09-08
- FDAMyLab Alpha, Model 74002018-06-11
- FDAMyLab Gamma, Model 74102018-06-11
- FDAMyLab Seven, Model 64002018-06-11
- FDAMyLab Ultrasound System; Models 6100, 6150, 6200, 6250; PA023E Probe 7.5/102018-01-03
- FDAMagnetic Resonance System G-scan Brio (Part Number /Model No.101002000)2016-06-06
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