Device recall
Z-0820-2020: Koios DS Breast. The device is a software application which assists skilled…
FDA device recall · Class II · Koios Medical, Inc.
Key facts
| Recall number (Z-number) | Z-0820-2020 |
|---|---|
| Recall event | 84615 |
| Product | Koios DS Breast . The device is a software application which assists skilled physicians in analyzing breast ultrasound images. |
| Product code | LLZ |
| Recalling firm | Koios Medical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 7, 2020 |
| 510(k) numbers | K161959 |
| FEI number | 3010119782 |
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