Reported Mar 28, 2018 · Terminated
MyLab Ultrasound System; Models 6100, 6150, 6200, 6250; PA023E Probe 7.5/10
Esaote S.p.a.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ESAOTE S.P.A. · Sesto Fiorentino · Sesto Fiorentino, N/A · N/A
Is this the product you have?
MyLab Ultrasound SystemModels 6100615062006250PA023E Probe 7.5/10
- Lot codes and dates
- Software versions 4.0 - 13.60
- Amount recalled
- 1
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
The ultrasound system used in certain settings may result in overheating of the ultrasound probe head.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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