Drug recall
NeuViz 64 Multi-Slice CT Scanner System (consist if two variants: NeuViz 64e, NeuViz 64i)
FDA recall event 73832 · Class II · Neusoft Medical Systems Co., Ltd.
Key facts
| Event ID | 73832 |
|---|---|
| Recall numbers | Z-1650-2016 |
| Recalling firm | Neusoft Medical Systems Co., Ltd. |
| Product type | Devices |
| Products | NeuViz 64 Multi-Slice CT Scanner System (consist if two variants: NeuViz 64e, NeuViz 64i) |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | It was found by R&D in April, 2014 that there was a defect in NeuViz 64 system software version 1.0.5+P09. The icons of side decubitus didn't meet the patient position description, when the scanner… |
| Initiation date | May 2, 2015 |
| Report date | May 18, 2016 |
| Termination date | Nov 4, 2016 |
| 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: