Drug recall
Neusoft Medical NeuViz 64 Multi-slice CT Scanner System, including: NeuViz 64e, NeuViz 64i with software…
FDA recall event 77608 · Class II · Neusoft Medical Systems Co., Ltd.
Key facts
| Event ID | 77608 |
|---|---|
| Recall numbers | Z-3044-2017, Z-3045-2017 |
| Recalling firm | Neusoft Medical Systems Co., Ltd. |
| Product type | Devices |
| Products | Neusoft Medical NeuViz 64 Multi-slice CT Scanner System, including: NeuViz 64e, NeuViz 64i with software version 1.0.6.3258 +P11 or previous version, NeuViz 64En, NeuViz 641n with software version…, Neusoft NeuViz 128 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | FDA Requested |
| Reason for recall | Software defect |
| Initiation date | May 19, 2017 |
| Report date | Sep 6, 2017 |
| Termination date | Nov 19, 2020 |
| City | Shenyang |
| Country | China |
| FEI number | 3003575350 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: