FDA Device recall Z-0466-2013
NeuViz 16 Multi-Sliced CT Scanner System, part number 989605858501
- FDA Device
- Class II
- terminated
- Published 2012-12-12
On 2012-12-12 the FDA classified a Class II recall of NeuViz 16 Multi-Sliced CT Scanner System, part number 989605858501 by Philips And Neusoft Medical Systems, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0466-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-10-18 |
| Published | 2012-12-12 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Philips And Neusoft Medical Systems |
| Distribution | US |
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
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.
Identifiers
| code_info | NeuViz 16 system Serial numbers: N16E090002, N16E090003, N16E090004, N16E090007, N16E090008, N16E090010, N16E100015,…NeuViz 16 system Serial numbers: N16E090002, N16E090003, N16E090004, N16E090007, N16E090008, N16E090010, N16E100015, N16E100017, N16E100023, N16E110016, N16E110023, N16E110026, N16E110027, N16E110040, N16E110053, N16E120016, N16E120022, N16E120020, N16E120023, N16E120024. Neuviz Dual 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, and NDHR090013. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0466-2013%22
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