Device recall
Z-1785-2010: Passport V Monitor: Mindray, North America. Mindray DS USA, Inc. Mahwah, NJ…
FDA device recall · Class II · Mindray DS USA, Inc., dba Datascope Patient Monitoring
Key facts
| Recall number (Z-number) | Z-1785-2010 |
|---|---|
| Recall event | 55572 |
| Product | Passport V Monitor: Mindray, North America. Mindray DS USA, Inc. Mahwah, NJ 07430. Intended for intra hospital use under the direct supervision of a healthcare practitioner for the monitoring of various human physiological parameters. |
| Product code | MHX |
| Recalling firm | Mindray DS USA, Inc., dba Datascope Patient Monitoring |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 22, 2011 |
| 510(k) numbers | K091834 |
| 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