Device recall
Z-0798-2013: Mindray DS USA, Inc., DPM Central Monitoring System with ambulatory Telepack…
FDA device recall · Class II · Mindray DS USA, Inc. d.b.a. Mindray North America
Key facts
| Recall number (Z-number) | Z-0798-2013 |
|---|---|
| Recall event | 64114 |
| Product | Mindray DS USA, Inc., DPM Central Monitoring System with ambulatory Telepack. Part numbers: 300BF-PA00002, and 300BF-PA00003 (DPM Central Monitoring System) 115-006908-01, -03, -04 (DPM software upgrade kit). The DPM Central Monitoring System transfers information between DPM Central station and… |
| Product code | MSX |
| Recalling firm | Mindray DS USA, Inc. d.b.a. Mindray North America |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 15, 2013 |
| 510(k) numbers | K080192 |
| FEI number | 2221819 |
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