Device recall
Z-0435-2026: 1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with…
FDA device recall · Class II · B-K Medical A/S
Key facts
| Recall number (Z-number) | Z-0435-2026 |
|---|---|
| Recall event | 97830 |
| 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 |
| Product code | IYN |
| Recalling firm | B-K Medical A/S |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K132335 |
| FEI number | 3003705156 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database