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Biosound Esaote, Inc. recalls Esaote PA230E Transducer A portable and cart base ultrasound system for general and cardiovascular imaging
Recalled August 20, 2014 · FDA recall Z-2167-2014 · Biosound Esaote
Hazard
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. · FDA Class II
Units
1,301 units
Sold at
Nationwide-Product was shipped to the following states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI & WV. International**Product was also shipped to consignees in Canada
Description
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.
Product
Esaote PA230E Transducer A portable and cart base ultrasound system for general and cardiovascular imaging
Manufacturer(s)
Biosound Esaote, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →