bk5000 Ultrasound System w/battery — Class II medical device recall Z-0440-2026
Ongoing recall by B-K Medical A/S, reported 2025-11-12, distributed nationwide. GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not a
| Recall number | Z-0440-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | B-K Medical A/S, Herlev, N/A, Denmark |
| Recall initiated | 2025-10-09 |
| Classified | 2025-11-06 |
| Reported by FDA | 2025-11-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BG, BR, CA, CH, CL, CN, CO, CR, CZ, DE, DK, DZ, EC, EE, ES, FI, FR, GB, GR, HK, HR, HU, ID, IE, IL, IN, IS, IT, JP, KR, KW, LB, LU, LV, MA, MX, MY, NL, NO, NP, NZ, PA, PE, PH, PK, PL, PT, QA, RO, RS, RU, SA, SE, SG, SI, SK, TH, TW, UA, ZA |
| Quantity | 895 units |
| UPC / GTIN / UDI-DI | 05704916000264 |
| Serial numbers | 2000116, 2000118, 2000119, 2000610, 2000611, 2000614, 2000616, 2000617, 2000618, 2000619, 2000660, 2000661, 2000662, 2000663, 2000664, 2000665, 2000668, 2000669, 2000721, 2000722, 2000723, 2000724, 2000725, 2000726, 2000727 and 475 more |
| Model numbers | 2300-61 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0440-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.