Recall Z-0435-2026— B-K Medical A/S

Name: FDA recall Z-0435-2026
Creator: U.S. Food and Drug Administration
Published: 2025-10-09

Class II · Ongoing

Class II FDA medical device recall by B-K Medical A/S, initiated 2025-10-09. It names one FDA 510(k) clearance: K132335. Product: 1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic. Reason: GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-life handling procedures, or general battery safety precautions..

Recalling firm: B-K Medical A/S
Classification: Class II
Status: Ongoing
Initiated: 2025-10-09
Firm location: Herlev, N/A, Denmark

510(k) clearances named in this recall

1 on FDA's record

K132335 — ULTRASOUND SCANNER FLEX FOCUS 1202B-K Medical Aps·cleared 2014-01-10

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

1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

Reason for recall

GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-life handling procedures, or general battery safety precautions.

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