Device recall
Z-2280-2023: NanoZoomer S360MD Slide scanner system-automated system for creating, viewing…
FDA device recall · Class II · Hamamatsu Corporation
Key facts
| Recall number (Z-number) | Z-2280-2023 |
|---|---|
| Recall event | 92627 |
| Product | NanoZoomer S360MD Slide scanner system-automated system for creating, viewing, and managing digital slides. The NanoZoomer System creates diagnostic-quality digital images of glass slides containing formalin-fixed paraffin-embedded (FFPE) tissue. Catalog Number: C13220-01MD |
| Product code | PSY |
| Recalling firm | Hamamatsu Corporation |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K213883 |
| FEI number | 1000121818 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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