United StatesUltrasound systems from B‑K Medical A/S are affected, including the 1202 Flex Focus Ultrasound System (cart models UA1214 and UA1814 used with Flex Focus 200, 300, 400, 500, 700 and 800) and portable systems 1300 (bkSpecto, model 1300‑21 or 1300‑S1), 2300 (bkActiv, model 2300‑11), bk3000 (model 2300‑66), bk3500 (model 2300‑41) and bk5000 (model 2300‑61); affected units include GTIN 05704916001056 and multiple listed serial numbers. The recall was issued because the Instructions for Use and service manual do not adequately state required battery replacement intervals, end‑of‑life handling procedures, or general battery safety precautions.
What's being recalled
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
Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic
UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic
bk3000 Ultrasound System w/battery; Model No. 2300-66; System, Imaging, Pulsed Doppler, Ultrasonic
bk3500 Ultrasound System w/battery; Model No. 2300-41; System, Imaging, Pulsed Doppler, Ultrasonic
bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic
Recalling firm: B-K Medical A/S, Herlev, N/A, Denmark.
How to identify it
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, 4100070, 4100127, 4100194, 4100819, 4100822, 4100839, 4100870, 4100873, 4101526, 4101554, 4101632, 4101646, 4101677, 4101803, 4101828, 4101836, 4101863, 4101867, 4101983, 4102012, 4102015, 4102105, 4005729, 4102419, 4100133, 4005972, 4102328, 4102417, 4004344, 1910010, 4004855, 4006810, 4003561, 4005461, 4101634, 4100330, 4006425, 4101099, 4004192, 4005257, 4006943, 1907405, 1907367, 4002579, 4100225, 4101206, 4005868, 4005872, 4102993, 4101253, 4001126, 4005184, 4003763, 4001414, 4001692…
The 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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
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.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)