FDA Medical devices recall ·
1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814… recall
- Recall number
- Z-0435-2026
- Date
- (initiated October 9, 2025)
- Company / brand
- B-K Medical A/S
Mileparken 34, Herlev, N/A, Denmark - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 4426 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
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 should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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
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.
States: Georgia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0435-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.