Recall Z-0136-2025 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
B-K Medical A/S
bk3000, model #2300-11; bk3500, model #2300-41; bk5000, model #2300-61; and bkActive 2300, model #2300-66, ultrasound system with battery option.
| Date | Oct 18, 2024 (initiated Sep 4, 2024) |
| Status | Open, Classified |
| Reason | The internal power connections at the power inlet of the ultrasound devices can come loose resulting in the potential for excessive heat which could lead to a thermal event or the device becoming inoperable. |
| Root cause | Process control |
| Action | Notifications were issued on and dated 9/4/2024 informing the consignee of the safety issue and the actions to be taken, which included: Until GE HealthCare implements a permanent correction on the device for this issue, the consignee is to inspect the power cord connection at the power inlet to the ultrasound device. A photograph of the area to be inspected was embedded in the letter. If a cord retaining bracket is not present, the consignee is to ensure the power cord is fully pushed into the power inlet before each use and while the ultrasound device is charging. If a cord retaining bra |
| Quantity | 1648 devices |
| Distribution | Worldwide - US Nationwide - There was also government/military distribution and the countries of Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, Greece, India, Indonesia, Ireland, Israe |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K223830 | Ultrasound System 2300 Bk Medical Aps, Apr 11, 2023 |