B-K Medical A/S: Medical Device Recall in 2024 - (Recall #: Z-0813-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 30, 2023

Date Posted: January 31, 2024

Recall Number: Z-0813-2024

Event ID: 93598

Reason for Recall:

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

Status: Ongoing

Product Quantity: N/A

Code Information:

All bkActive (2300-56 and 2300-66) Ultrasound systems, GTIN 05704916000264.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated