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B-K Medical A/S recalls bkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66.
Recalled January 31, 2024 · FDA recall Z-0813-2024 · B-K Medical A/S
Hazard
An issue on the Dual Live Compare feature on the bkActiv system could result in a measurement error. · FDA Class II
Units
N/A
Sold at
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.
Description
An issue on the Dual Live Compare feature on the bkActiv system could result in a measurement error.
Product
bkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66.
Manufacturer(s)
B-K Medical A/S
Made in
Denmark
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →