ESAOTE recalls specific MyLab ultrasound models due to potential probe overheating. Affected units include models 6100-6250 and listed probes. Contact ESAOTE for details.
The ultrasound system used in certain settings may result in overheating of the ultrasound probe head.
ESAOTE is recalling certain MyLab ultrasound systems and probes because they may overheat during use. This could cause injury if the probe gets too hot. Affected models and probes are listed in the recall notice.
The ultrasound probe heads may overheat when used in certain settings, potentially causing burns or other injuries. This happens because the system's design doesn't properly manage heat in specific usage scenarios.
Healthcare professionals using the recalled ultrasound systems and probes are most at risk. Patients using these systems may also be affected if the probe overheats.
Check if your ultrasound system is model 6100, 6150, 6200, or 6250. Also check for listed probe models like BL433 or C 18. The software version may be between 12.10 and 13.60.
Identify if your ultrasound system is one of the affected models (6100, 6150, 6200, 6250) or includes listed probes.
Reach out to ESAOTE directly for guidance on next steps and potential remedies.
The affected models are MyLab ultrasound systems 6100, 6150, 6200, 6250 and specific probes including BL433, C 18, CA541, EC1123, EC123, IH 618, IOT332, IOT342, L 415, LA332E, LA435, LA523, LA533, SI2C41, SL2325, TRT33.
Contact ESAOTE directly for guidance on next steps and potential remedies.
The recall states that overheating could occur, but the official notice does not specify if this leads to serious injury in normal use.
We’ve drafted a message you can send ESAOTE to request your refund or repair — edit it as you like.
Subject: Recall Z-1138-2018 — ESAOTE ESAOTE Hello, I own a ESAOTE that is covered by recall Z-1138-2018 from ESAOTE. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
