Reported Aug 20, 2014 · Terminated
Esaote PA230E Transducer A portable and cart base ultrasound system for general and cardiovascular imaging
Biosound Esaote, Inc.
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: Biosound Esaote, Inc. · 8000 Castleway Dr · Indianapolis, IN · 46250-1943
Is this the product you have?
- Esaote PA230E Transducer A portable and cart base ultrasound system for general and cardiovascular imaging
- Lot codes and dates
1,295 of 1,295 codes
Part #: 9600165000 PROBEPA230E Serial #'s: 0701110005100071001010011100121001310015100171002110042100681007010079100851008610087100881008910092101011010210117101391014910154101551016910170101761017710179101831018410194102031020510217102381024610247102841028510286102941030010301103031030510306103131031410318104821053310534105391054810559
- Amount recalled
- 1,301 units
Where it was sold
Why it was recalled
Using the PA230E transducer with a user-defined setting with the output power to 100% (Max) in 2D-TEI mode focusing at maximum depth, could cause the transducer surface temperature to exceed the maximum allowable limit.
This product could cause temporary or reversible health problems — stop using it.
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