Device recall
Z-1321-2023: Tempus Pro Patient Monitor is a portable vital signs monitor intended to be used…
FDA device recall · Class II · Remote Diagnostic Technologies Ltd.
Key facts
| Recall number (Z-number) | Z-1321-2023 |
|---|---|
| Recall event | 91805 |
| Product | Tempus Pro Patient Monitor is a portable vital signs monitor intended to be used by clinicians and medically qualified personnel, for the attended or unattended monitoring of single or multiple vital signs in clinical and pre hospital care applications. The affected power supplies are related to the… |
| Product code | MHX |
| Recalling firm | Remote Diagnostic Technologies Ltd. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K201746 |
| FEI number | 3003832357 |
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