Device recall
Z-0469-2014: Digital Pathology System (DPS) Software version 1.1 The Omnyx" Integrated…
FDA device recall · Class II · Omnyx Llc
Key facts
| Recall number (Z-number) | Z-0469-2014 |
|---|---|
| Recall event | 66596 |
| Product | Digital Pathology System (DPS) Software version 1.1 The Omnyx" Integrated Digital Pathology system, which consists of a whole slide scanner and associated software applications, is a scanning, receiving, storing, managing, annotating and computer monitor viewing system for digital whole slide… |
| Product code | OTU |
| Recalling firm | Omnyx Llc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 16, 2014 |
| FEI number | 3008491142 |
At a glance
- None 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