FDA-Device2014-08-20Class II
Esaote PA230E Transducer A portable and cart base ultrasound system for general and cardiovascular imaging
Biosound Esaote, Inc.
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.
Sold states
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
Affected count
1,301 units
Manufactured in
8000 Castleway Dr, N/A, Indianapolis, IN, United States
Products
Esaote PA230E Transducer A portable and cart base ultrasound system for general and cardiovascular imaging
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2167-2014Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief