# FDA recall Z-0440-2026

> **B-K Medical A/S** · Class II · device recall initiated 2025-10-09.

## Product

bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic

## Reason for recall

GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-life handling procedures, or general battery safety precautions.

## Distribution

Worldwide distribution: US (nationwide) and OUS (foreign) to countries of: Algeria, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Rep, Ecuador, Estonia, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Korea (Republic Of), Kuwait, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Mongolia, Morocco, Nepal, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkiye, Ukraine, United Arab Emirates, and United Kingdom.

## Key facts

- **Recall number:** Z-0440-2026
- **Recalling firm:** B-K Medical A/S
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-10-09
- **Report date:** 2025-11-12

- **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-0440-2026

## Citation

> AI Analytics. FDA recall Z-0440-2026. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0440-2026. Source: US FDA. Licensed CC0.

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