# FDA recall Z-0813-2024

> **B-K Medical A/S** · Class II · device recall initiated 2023-11-30.

## 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

- **Recall number:** Z-0813-2024
- **Recalling firm:** B-K Medical A/S
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-11-30
- **Report date:** 2024-01-31

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Herlev, N/A, Denmark

## Primary source

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

## Citation

> AI Analytics. FDA recall Z-0813-2024. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-0813-2024. Source: US FDA. Licensed CC0.

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