Device recall
Z-2325-2016: BK Medical ApS Ultrasound System Scanner bk2300 - Model #: bk3500 with software…
FDA device recall · Class II · B-K Medical A/S
Key facts
| Recall number (Z-number) | Z-2325-2016 |
|---|---|
| Recall event | 74691 |
| Product | BK Medical ApS Ultrasound System Scanner bk2300 - Model #: bk3500 with software releases 1.2.0, 1.2.1 and 1.2.2. The system is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body, data processing and guidance of puncture and biopsy. The system performs simple… |
| Product code | IYN |
| Recalling firm | B-K Medical A/S |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 29, 2016 |
| 510(k) numbers | K140428, K143298, K151910, K152052 |
| 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