NeuViz Dual series CT Scanner System — Class II medical device recall Z-1166-2013
Terminated recall by Philips And Neusoft Medical Systems Co., Ltd., reported 2013-05-01, distributed nationwide. User error of the NeuViz 16 or NeuViz Dual may cause personnel injuries. There was a report where a finger was
| Recall number | Z-1166-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips And Neusoft Medical Systems Co., Ltd., Shenyang, Liaoning, China |
| Recall initiated | 2013-03-04 |
| Classified | 2013-04-23 |
| Reported by FDA | 2013-05-01 |
| Terminated | 2013-11-22 |
| Distributed | Nationwide (US) |
| Quantity | 25 units |
| Serial numbers | 400562, 400563, 400626, NDH009EI, NDH011EI, NDH012EI, NDH013EI, NDH016EI, NDH017EI, NDH026EI, NDH027EI, NDH028EI, NDH030EI, NDH031EI, NDH034EI, NDHR080001, NDHR080002, NDHR080003, NDHR080004, NDHR080007, NDHR080012, NDHR080021, NDHR090003, NDHR090012, NDHR090013 |
| Model numbers | 989605651321 |
Product
NeuViz Dual series CT Scanner System, Part number (PN): 989605651321. This is a computed X-ray, Tomography system. NeuViz Dual Multi-slice CT Scanner System is intended to produce cross-section images of head and body by computer reconstruction of X-ray transmission data taken at different angles.
Reason for recall
User error of the NeuViz 16 or NeuViz Dual may cause personnel injuries. There was a report where a finger was pinched when the table was moved backward while the tabletop was controlled by another person from the gantry left control panel.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.