Device recall
Z-0109-2027: ePM Series Patient Monitor. Patient Monitor Series: ePM 10M/ePM 12M/ePM 12MA/…
FDA device recall · Class III · Mindray DS USA, Inc.
Key facts
| Recall number (Z-number) | Z-0109-2027 |
|---|---|
| Recall event | 99828 |
| Product | ePM Series Patient Monitor. Patient Monitor Series: ePM 10M/ePM 12M/ePM 12MA/ ePM 15M/ePM 10A |
| Product code | MHX |
| Recalling firm | Mindray DS USA, Inc. |
| Recall class | Class III |
| Status | Open, Classified |
| 510(k) numbers | K260098 |
| 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