Device recall
Z-0773-2019: NeuViz 128 Multi-slice CT Scanner System with software version 1.0.8.5010O+P04…
FDA device recall · Class II · NEUSOFT MEDICAL SYSTEMS IMP & EX
Key facts
| Recall number (Z-number) | Z-0773-2019 |
|---|---|
| Recall event | 81920 |
| Product | NeuViz 128 Multi-slice CT Scanner System with software version 1.0.8.5010O+P04 Vi .0.8.521 9+PO1 Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array. The acquired X-RAY transmission data is… |
| Product code | JAK |
| Recalling firm | NEUSOFT MEDICAL SYSTEMS IMP & EX |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 25, 2022 |
| 510(k) numbers | K151383 |
| FEI number | 3012245681 |
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