B-K Medical A/S recalls 1202 Flex Focus Ultrasound System

Recalling company

B-K Medical A/S

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.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Oct 9, 2025

Reported

Nov 12, 2025

Distribution

Worldwide distribution: US (nationwide) and OUS (foreign) to countries of: Algeria, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Rep, Ecuador, Estonia, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Korea (Republic Of), Kuwait, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Mongolia, Morocco, Nepal, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkiye, Ukraine, United Arab Emirates, and United Kingdom.

Status

Ongoing

Quantity

4426 units

Lot / codes

1) GTIN 05704916001056, Serial Numbers: 4005090, 4005710, 4002577, 4001807, 4002211, 4004085, 4006424, 4004772, 4101695, 4006420, 4100894, 4003775, 4004724, 4000321, 4004803, 4101755, 4101757, 4004635, 4004641, 4003082, 4004188, 4004448, 4100213, 4101302, 4000466, 4002982, 4006605, 4004941, 4100713, 4003569, 4003390, 4006608, 4101728, 4101906, 4005490, 4100128, 4001502, 4005922, 4006602, 4101724, 4005913, 4101394, 4001066, 4005230, 4000771, 4001536, 4003417, 4004297, 4102893, 4103104, 4003275, 4004575, 4100395, 4004038, 4004201, 4006350, 4100035, 4006123, 4100092, 4005380, 4005961, 4000460, 4005679, 4001915, 4005334, 4005346, 4001503, 4001694, 4003141, 4003626, 4004412, 4004431, 4005447, 4100060, 4005190, 4002880, 4101872, 4004088, 4004339, 4102033, 4005920, 4101823, 4007095, 4005228, 4004443, 4101990, 4002023, 4002190, 4005993, 4004423, 4101552, 4006362, 4001532, 4100603, 4005243, 4006010, 4006113, 4006114, 4006117, 4006126, 4101988, 4006950, 4006815, 4005778, 4101506, 4102036, 1909816, 4101756, 4002916, 4005906, 4101758, 4003821, 4005258, 4003139, 4101504, 4003884, 4005352, 4005769, 4005771, 4101555, 4003052, 4100463, 4007074, 4100140, 4002947, 4001137, 4006812, 4001266, 4005650, 4101956, 4003731, 4006409, 4004632, 4005337, 4100943, 4102414, 1910262, 4000166, 4101225, 4003164, 4001683, 4005372, 1910167, 4001651, 4005649, 4002186, 4101725, 4101991, 4000074, 4000845, 4001946, 4004994, 4007036, 4007038, 4007039, 4007040, 4007042, 4007053, 4100040, 4100057, 4100068, 4100069, 4

Company location

Herlev, N/A

Recall type

Voluntary: Firm initiated

Recall number

Z-0435-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-0435-2026 in the FDA Enforcement Report. Also see FDA recall press releases.