NeuViz 16 Multi-Sliced CT Scanner System — Class II medical device recall Z-0466-2013
Terminated recall by Philips And Neusoft Medical Systems Co., Ltd., reported 2012-12-12, distributed nationwide. The four screws that secure the patient table top to the carrier pulled out and caused the table top to detach
| Recall number | Z-0466-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips And Neusoft Medical Systems Co., Ltd., Shenyang, Liaoning, N/A, China |
| Recall initiated | 2012-10-18 |
| Classified | 2012-12-04 |
| Reported by FDA | 2012-12-12 |
| Terminated | 2013-07-08 |
| Distributed | Nationwide (US) |
| Reason classes | device malfunction |
| Serial numbers | 400562, 400563, 400626, N16E090002, N16E090003, N16E090004, N16E090007, N16E090008, N16E090010, N16E100015, N16E100017, N16E100023, N16E110016, N16E110023, N16E110026, N16E110027, N16E110040, N16E110053, N16E120016, N16E120020, N16E120022, N16E120023, N16E120024, NDH009EI, NDH011EI and 20 more |
| Model numbers | 989605651321, 989605858501 |
Product
NeuViz 16 Multi-Sliced CT Scanner System, part number 989605858501. NeuViz Dual series CT Scanner System, part number 989605651321 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.
Reason for recall
The four screws that secure the patient table top to the carrier pulled out and caused the table top to detach. This issue may affect NeuViz Dual and NeuViz 16 scanners.
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.