B-K Medical A/S: 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, Im

Hazard

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.

Details from the source

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. 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), Kuwai Quantity: 4426 units Lot/code info: 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, 41

UPC codes

05704916001056

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.