FDA Device recall Z-1165-2013
NeuViz 16 Multi-Slice CT Scanner System, Part number (PN): 989605858501, Model: NeuViz 16
- FDA Device
- Class II
- terminated
- Published 2013-05-01
On 2013-05-01 the FDA classified a Class II recall of NeuViz 16 Multi-Slice CT Scanner System, Part number (PN): 989605858501, Model: NeuViz 16 by Philips And Neusoft Medical Systems, citing 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 con….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1165-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-03-04 |
| Published | 2013-05-01 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Philips And Neusoft Medical Systems |
| Distribution | US |
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
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.
Identifiers
| code_info | Serial numbers: N16E090002, N16E090003, N16E090004, N16E090007, N16E090008, N16E090010, N16E100015, N16E100017, N16E10…Serial numbers: N16E090002, N16E090003, N16E090004, N16E090007, N16E090008, N16E090010, N16E100015, N16E100017, N16E100023, N16E110016, N16E110023, N16E110026, N16E110027, N16E110040, N16E110053, N16E120016, N16E120020, N16E120022, N16E120023, N16E120024, N16E120052, N16E120053, and N16E130002. |
|---|
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-1165-2013%22
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