Device recall
Z-2183-2011: TEMPUS IC PROFESSIONAL Patient Monitor, Part No. 00-1002, Manufactured by…
FDA device recall · Class II · Remote Diagnostic Technologies Ltd.
Key facts
| Recall number (Z-number) | Z-2183-2011 |
|---|---|
| Recall event | 58479 |
| Product | TEMPUS IC PROFESSIONAL Patient Monitor, Part No. 00-1002, Manufactured by: Remote Diagnostics Technologies Ltd., The Old Coach House, Farleigh Wallop, Hants, UK RG25 2HT. Indicated for 3 Lead ECG monitoring and 12 Lead ECG recording, non-invasive blood pressure (NIBP), respiration, end-tidal C02… |
| Product code | MWI |
| Recalling firm | Remote Diagnostic Technologies Ltd. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 16, 2011 |
| 510(k) numbers | K101264 |
| 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