Recall Z-0440-2026— B-K Medical A/S
Class II · Ongoing
Class II FDA medical device recall by B-K Medical A/S, initiated 2025-10-09. It names one FDA 510(k) clearance: K223830. Product: bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic. Reason: 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..
- Recalling firm
- B-K Medical A/S
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-10-09
- Firm location
- Herlev, N/A, Denmark
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.