Device recall
Z-2549-2016: Mindray DS USA Inc., Passport Series Patient Monitor intended for monitoring…
FDA device recall · Class II · Mindray DS USA, Inc. dba Mindray North America
Key facts
| Recall number (Z-number) | Z-2549-2016 |
|---|---|
| Recall event | 74704 |
| Product | Mindray DS USA Inc., Passport Series Patient Monitor intended for monitoring, displaying, reviewing, alarming, and transferring of multiple physiological parameters including ECG (3-lead, 5-lead or 12-lead selectable, arrythmia detection, ST segment analysis, and heart rate (HR), Respiration rate. |
| Product code | MHX |
| Recalling firm | Mindray DS USA, Inc. dba Mindray North America |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 28, 2017 |
| 510(k) numbers | K143195 |
| 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