FDA recall Z-0813-2024

B-K Medical A/S · Class II · device

Product

bkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66.

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.

Key facts

Status: Ongoing
Initiation date: 2023-11-30
Report date: 2024-01-31
Voluntary/Mandated: Voluntary: Firm initiated
Location: Herlev, N/A, Denmark

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0813-2024