Device recall
Z-0557-2025: Tempus LS-Manual Defibrillator Model 00-3020 The Tempus LS-Manual is a…
FDA device recall · Class III · Remote Diagnostic Technologies Ltd.
Key facts
| Recall number (Z-number) | Z-0557-2025 |
|---|---|
| Recall event | 95642 |
| Product | Tempus LS-Manual Defibrillator Model 00-3020 The Tempus LS-Manual is a defibrillator that can deliver a shock in manual or Pacemaker mode |
| Product code | LDD |
| Recalling firm | Remote Diagnostic Technologies Ltd. |
| Recall class | Class III |
| Status | Open, Classified |
| 510(k) numbers | K200849 |
| FEI number | 3003832357 |
At a glance
- 1–9 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