Device recall
Z-0564-2021: Tempus LS - Manual Defibrillator, Model Number: 00-3020 Software Version: 1.3.4…
FDA device recall · Class II · Remote Diagnostic Technologies Ltd.
Key facts
| Recall number (Z-number) | Z-0564-2021 |
|---|---|
| Recall event | 86801 |
| Product | Tempus LS - Manual Defibrillator, Model Number: 00-3020 Software Version: 1.3.4 - Product Usage: The device is intended to be used in the following environmental: - Primarily in pre-hospital care and transport applications (including ambulances, fixed and rotary wing aircraft). |
| Product code | LDD |
| Recalling firm | Remote Diagnostic Technologies Ltd. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 12, 2023 |
| 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