Device recall
Z-0513-2013: DPM 6/7 Patient Monitor Manufactured in China for: Mindray DS USA, Inc. 800…
FDA device recall · Class II · Mindray DS USA, Inc. d.b.a. Mindray North America
Key facts
| Recall number (Z-number) | Z-0513-2013 |
|---|---|
| Recall event | 63614 |
| Product | DPM 6/7 Patient Monitor Manufactured in China for : Mindray DS USA, Inc. 800 MacArthur Blvd. Mahwah, NJ 07430 USA. Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead or 12-lead selectable). arrhythmia… |
| Product code | MHX |
| Recalling firm | Mindray DS USA, Inc. d.b.a. Mindray North America |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 2, 2013 |
| 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