Device recall
Z-1997-2021: Tempus Pro - Patient physiological monitor, arrhythmia detector and alarm. Part…
FDA device recall · Class II · Remote Diagnostic Technologies Ltd.
Key facts
| Recall number (Z-number) | Z-1997-2021 |
|---|---|
| Recall event | 88051 |
| Product | Tempus Pro - Patient physiological monitor, arrhythmia detector and alarm. Part No. - 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R. Product Usage: intended to be used as a stand-alone monitor or as a telemedicine system (transmitting patient data to other medical professionals located elsewhere). |
| 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