Class II

Medical Device Recall: bkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66.

B-K Medical A/S · November 30, 2023

Reason for Recall

An issue on the Dual Live Compare feature on the bkActiv system could result in a measurement error.

Distribution

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.

States Affected

NATIONWIDE

Quantity Affected

N/A

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0813-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

B-K Medical A/S Medical Device Recall: bkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66. | SafeCheck