FDA-Device2024-01-31Class II
bkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66.
B-K Medical A/S
Hazard
An issue on the Dual Live Compare feature on the bkActiv system could result in a measurement error.
Sold states
US Nationwide distribution including in the states of AL, AZ, CA, FL, GA, ID, IL, KS, MA, MD, MI, MO, NC, NE, NJ, NY, OH, PA, RI, SC, TX, UT, VA, WA, WI, and WV.
Affected count
N/A
Manufactured in
Mileparken 34, N/A, Herlev, N/A, Denmark
Products
bkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0813-2024Don't want to check this manually?
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