Device recall
Z-1254-2021: Mindray BeneVision Distributed Monitoring System( DMS) 1. p/n 115-051209-00 2…
FDA device recall · Class II · Mindray DS USA, Inc. dba Mindray North America
Key facts
| Recall number (Z-number) | Z-1254-2021 |
|---|---|
| Recall event | 87380 |
| Product | Mindray BeneVision Distributed Monitoring System( DMS) 1. p/n 115-051209-00 2. p/n 115-034414-00 and 115-034413-00 when used with the following software versions: 03.04.00 04.01.00 04.03.00 04.04.00 04.04.01 |
| Product code | MSX |
| Recalling firm | Mindray DS USA, Inc. dba Mindray North America |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K193391 |
| 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