Recall Z-0435-2026 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
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, Imaging, Pulsed Doppler, Ultrasonic
| Date | Nov 6, 2025 (initiated Oct 9, 2025) |
| Status | Open, Classified |
| 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. |
| Root cause | Device Design |
| Action | GE Healthcare issued an "URGENT MEDICAL DEVICE CORRECTION NOTICE" to its consignees on 10/09/2025 via traceable means. The notice explained the issue, potential risk, and requested: "Actions to be taken by Customer / User You can continue to use your device by following the instructions below: 1. Review and follow the applicable addendums to the Instructions for Use and the updated Service Manuals. The Addendums and Service Manuals are available for download at: https://www.gehealthcare.com/support/manuals. 2. Follow the conditions defined within the addendum and Service Manual applicab |
| Quantity | 4426 units |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132335 | ULTRASOUND SCANNER FLEX FOCUS 1202 B-K Medical Aps, Jan 10, 2014 |