Device recall
Z-0846-2011: The device is the NeuViz Dual series Computed Tomography (CT) Scanner System…
FDA device recall · Class II · Philips And Neusoft Medical Systems Co., Ltd.
Key facts
| Recall number (Z-number) | Z-0846-2011 |
|---|---|
| Recall event | 54638 |
| Product | The device is the NeuViz Dual series Computed Tomography (CT) Scanner System. The device is identified as NeuViz Dual, PN: 989605651321. Labeling on the device reads in part: "***Neusoft NeuViz Dual MULTI-SLICE CT SCANNER SYSTEM***MANUFACTURED BY PHILIPS AND NEUSOFT MEDICAL SYSTEMS CO., LTD… |
| Product code | JAK |
| Recalling firm | Philips And Neusoft Medical Systems Co., Ltd. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 15, 2011 |
| 510(k) numbers | K062451, K071308 |
| FEI number | 3003575350 |
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