Device recall
Z-1573-2016: NeuViz 16 Multi-Slice CT Scanner System PN: 989605858501 a whole body computed…
FDA device recall · Class II · Philips and Neusoft Medical Systems Co., Ltd.
Key facts
| Recall number (Z-number) | Z-1573-2016 |
|---|---|
| Recall event | 73741 |
| Product | NeuViz 16 Multi-Slice CT Scanner System PN: 989605858501 a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multi-slice capability up to 16 slices simultaneously. |
| Product code | JAK |
| Recalling firm | Philips and Neusoft Medical Systems Co., Ltd. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 23, 2016 |
| 510(k) numbers | K090173, K092742 |
| 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