FDA Device recall Z-0136-2025
bk3000, model #2300-11
- FDA Device
- Class II
- ongoing
- Published 2024-10-30
On 2024-10-30 the FDA classified a Class II recall of bk3000, model #2300-11 by B K Medical A S, citing the internal power connections at the power inlet of the ultrasound devices can come loose resulting in the potential for excessive heat which could lead to a thermal event or the….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0136-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-09-04 |
| Published | 2024-10-30 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | B K Medical A S |
| Distribution | US |
Product
bk3000, model #2300-11; bk3500, model #2300-41; bk5000, model #2300-61; and bkActive 2300, model #2300-66, ultrasound system with battery option.
Reason
The internal power connections at the power inlet of the ultrasound devices can come loose resulting in the potential for excessive heat which could lead to a thermal event or the device becoming inoperable.
Identifiers
| code_info | All serial numbers, 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-0136-2025%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.