Recall Z-0813-2024— B-K Medical A/S

Name: FDA recall Z-0813-2024
Creator: U.S. Food and Drug Administration
Published: 2023-11-30

Class II · Ongoing

Class II FDA medical device recall by B-K Medical A/S, initiated 2023-11-30. It names one FDA 510(k) clearance: K223830. 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..

Recalling firm: B-K Medical A/S
Classification: Class II
Status: Ongoing
Initiated: 2023-11-30
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

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.

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