FDA Device recall Z-0813-2024
bkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66
- FDA Device
- Class II
- ongoing
- Published 2024-01-31
On 2024-01-31 the FDA classified a Class II recall of bkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66 by B K Medical A S, citing an issue on the Dual Live Compare feature on the bkActiv system could result in a measurement error.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0813-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-11-30 |
| Published | 2024-01-31 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | B K Medical A S |
| Distribution | US |
Product
bkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66.
Reason
An issue on the Dual Live Compare feature on the bkActiv system could result in a measurement error.
Identifiers
| code_info | All bkActive (2300-56 and 2300-66) Ultrasound systems, GTIN 05704916000264. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0813-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.