bkActiv Ultrasound System 2300 — Class II medical device recall Z-0813-2024
Ongoing recall by B-K Medical A/S, reported 2024-01-31, distributed nationwide. An issue on the Dual Live Compare feature on the bkActiv system could result in a measurement error.
| Recall number | Z-0813-2024 |
|---|---|
| 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 | 2023-11-30 |
| Classified | 2024-01-25 |
| Reported by FDA | 2024-01-31 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 05704916000264 |
| Model numbers | 2300-56, 2300-66 |
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.
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-0813-2024. 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.