Device recall
Z-0861-2022: Tempus LS, Type DGE1, CAT 00-3010, REF 3.940590, Software version 1.3.5, UDI…
FDA device recall · Class II · Remote Diagnostic Technologies Ltd.
Key facts
| Recall number (Z-number) | Z-0861-2022 |
|---|---|
| Recall event | 89595 |
| Product | Tempus LS, Type DGE1, CAT 00-3010, REF 3.940590, Software version 1.3.5, UDI: (01)07613365001693 |
| Product code | LDD |
| Recalling firm | Remote Diagnostic Technologies Ltd. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 25, 2024 |
| FEI number | 3003832357 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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