Device recall
Z-1102-2012: V Series Monitor Mindray DS USA, Inc. 800 MacArthur Boulevard. Mahwah, NJ 07430…
FDA device recall · Class II · Mindray DS USA, Inc. d.b.a. Mindray North America
Key facts
| Recall number (Z-number) | Z-1102-2012 |
|---|---|
| Recall event | 60976 |
| Product | V Series Monitor Mindray DS USA, Inc. 800 MacArthur Boulevard. Mahwah, NJ 07430 The Indications for Use for the V Series include the monitoring of the following human physiological parameters: ECG waveform derived from 3, 5, 6 and 12 lead measurements Heart Rate Pulse Oximetry (Sp02) ST Segment… |
| Product code | DRT |
| Recalling firm | Mindray DS USA, Inc. d.b.a. Mindray North America |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 11, 2013 |
| FEI number | 2221819 |
At a glance
- None 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