Device recall
Z-1611-2014: DPM 6 Monitor in use with a Multi Parameter Module (MPM). Patient monitor used…
FDA device recall · Class II · Mindray DS USA, Inc. dba Mindray North America
Key facts
| Recall number (Z-number) | Z-1611-2014 |
|---|---|
| Recall event | 67932 |
| Product | DPM 6 Monitor in use with a Multi Parameter Module (MPM). Patient monitor used for monitoring, displaying, reviewing, storing, and alarming of multiple physiological parameters including ECG, arrhythmia detection, ST segment analysis, heart rate (HR), respiration rate (RESP), temperature, pulse… |
| Product code | MHX |
| Recalling firm | Mindray DS USA, Inc. dba Mindray North America |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 27, 2015 |
| 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