B-K Medical A/S: Device Recall
Recall #Z-0440-2026 · 10/09/2025
Recall Details
- Recall Number
- Z-0440-2026
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- B-K Medical A/S
- Status
- Ongoing
- Date Initiated
- 10/09/2025
- Location
- Herlev, N/A, Denmark
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 895 units
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.
Product Description
bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic
Distribution Pattern
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.
Other Recalls by B-K Medical A/S
- Class II: Risk 10/09/2025
- Class II: Risk 10/09/2025
- Class II: Risk 10/09/2025
- Class II: Risk 10/09/2025
- Class II: Risk 10/09/2025