Device recall
Z-0963-2022: The Sight OLO device is a computer vision based platform for blood analysis. The…
FDA device recall · Class II · SIGHT DIAGNOSTICS LTD
Key facts
| Recall number (Z-number) | Z-0963-2022 |
|---|---|
| Recall event | 89645 |
| Product | The Sight OLO device is a computer vision based platform for blood analysis. The platform combines computer-vision algorithms for image processing to identify and quantify blood components (e.g., red blood cells) and their characteristics (e.g., cell volume) in an automated fashion. Using dedicated… |
| Product code | GKZ |
| Recalling firm | SIGHT DIAGNOSTICS LTD |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K190898 |
| FEI number | 3016099075 |
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