Device recall
Z-0528-2013: Mindray V12 Size: 320 mm X 320 mm X 450 mm N.W.: 3 kg G.W.: 6 kg Qty:1…
FDA device recall · Class II · Mindray DS USA, Inc. d.b.a. Mindray North America
Key facts
| Recall number (Z-number) | Z-0528-2013 |
|---|---|
| Recall event | 63652 |
| Product | Mindray V12 Size: 320 mm X 320 mm X 450 mm N.W.: 3 kg G.W.: 6 kg Qty:1 Manufactured in China Mindray V21 Size: 515 mm X 335 mm X 685 mm N.W.: 8 kg G.W.: 11 kg Qty:1 Manufactured in China One product, V Series monitor, available in two sizes: The V12 has a 12 inch screen, the V21 has a 21 inch… |
| Product code | MHX |
| Recalling firm | Mindray DS USA, Inc. d.b.a. Mindray North America |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 15, 2013 |
| 510(k) numbers | K102004 |
| 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