Drug recall
Neusoft NeuViz 64 Multi-slice CT Scanner System
FDA recall event 71306 · Class II · Neusoft Medical System Co
Key facts
| Event ID | 71306 |
|---|---|
| Recall numbers | Z-1693-2015 |
| Recalling firm | Neusoft Medical System Co |
| Product type | Devices |
| Products | Neusoft NeuViz 64 Multi-slice CT Scanner System |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The A-plane compensator is made of Teflon which will become fragile due to X-ray exposure passing through it. The thinnest part of the compensator is subject to radiation degradation and as a result… |
| Initiation date | Mar 8, 2014 |
| Report date | Jun 24, 2015 |
| Termination date | Dec 5, 2016 |
| City | Houston |
| State | TX |
| Country | United States |
| FEI number | 3010374379 |
At a glance
- 1–9 Products in this recall
- None 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: