Recall Z-0136-2025— B-K Medical A/S

Name: FDA recall Z-0136-2025
Creator: U.S. Food and Drug Administration
Published: 2024-09-04

Class II · Ongoing

Class II FDA medical device recall by B-K Medical A/S, initiated 2024-09-04. It names one FDA 510(k) clearance: K223830. 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..

Recalling firm: B-K Medical A/S
Classification: Class II
Status: Ongoing
Initiated: 2024-09-04
Firm location: Herlev, N/A, Denmark

510(k) clearances named in this recall

1 on FDA's record

K223830 — Ultrasound System 2300Bk Medical Aps·cleared 2023-04-11

K-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

bk3000, model #2300-11; bk3500, model #2300-41; bk5000, model #2300-61; and bkActive 2300, model #2300-66, ultrasound system with battery option.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.