NeuViz 16 Multi-Slice CT Scanner System — Class II medical device recall Z-1165-2013
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-1165-2013 |
|---|---|
| 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 | 23 units |
| Serial numbers | N16E090002, N16E090003, N16E090004, N16E090007, N16E090008, N16E090010, N16E100015, N16E100017, N16E100023, N16E110016, N16E110023, N16E110026, N16E110027, N16E110040, N16E110053, N16E120016, N16E120020, N16E120022, N16E120023, N16E120024, N16E120052, N16E120053, N16E130002 |
| Model numbers | 989605858501 |
Product
NeuViz 16 Multi-Slice CT Scanner System, Part number (PN): 989605858501, Model: NeuViz 16. This is a computed X-ray, Tomography system. The NeuViz 16 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 with multi-slice capability up to 16 slices simultaneously. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from the same axial plane taken at different angles. The system is suitable for all patients
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.