Device recall
Z-0837-2015: DPM 6 Patient Monitor and DPM 7 Patient Monitor. The product affected is the…
FDA device recall · Class II · Mindray DS USA, Inc. dba Mindray North America
Key facts
| Recall number (Z-number) | Z-0837-2015 |
|---|---|
| Recall event | 69788 |
| Product | DPM 6 Patient Monitor and DPM 7 Patient Monitor. The product affected is the Mindray IBP module, P/N is 6800-30-50485 for use with Mindray DPM 6 and DPM 7 patient monitors . Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters. |
| Product code | MHX |
| Recalling firm | Mindray DS USA, Inc. dba Mindray North America |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 6, 2017 |
| 510(k) numbers | K092449 |
| FEI number | 2221819 |
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