FDA Device recall Z-2083-2012
NeuViz 16 Multi-Slice CT Scanner System is a computed Tomography X-ray system, and has a Part number 989605858501
- FDA Device
- Class II
- terminated
- Published 2012-08-01
On 2012-08-01 the FDA classified a Class II recall of NeuViz 16 Multi-Slice CT Scanner System is a computed Tomography X-ray system, and has a Part number 989605858501 by Philips And Neusoft Medical Systems, citing one of the four screws that secure the Oil-accumulator to the X-Ray Tube pulled out in the NeuViz 16 CT scanner, which caused the Oil-accumulator to detach.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2083-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-06-08 |
| Published | 2012-08-01 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Philips And Neusoft Medical Systems |
| Distribution | US |
Product
NeuViz 16 Multi-Slice CT Scanner System is a computed Tomography X-ray system, and has a Part number 989605858501. The device is labeled in part: "***Neusoft***NeuViz16 MULTI-SLICE CT SCANNER SYSTEM***MANUFACTURED FOR NEUSOFT MEDICAL SYSTEMS CO., LTD***MANUFACTURED BY PHILIPS AND NEUSOFT MEDICAL SYSTEMS CO., LTD***ADDRESS: NEUSOFT PARK, HUNNAN INDUSTRIAL AREA, SHENYANG***CHINA***".
Reason
One of the four screws that secure the Oil-accumulator to the X-Ray Tube pulled out in the NeuViz 16 CT scanner, which caused the Oil-accumulator to detach.
Identifiers
| code_info | Serial No.: N16E0 90002, N16E0 90003, N16E0 90004, N16E0 90007, N16E0 90008, N16E0 90010, N16E1 00015, N16E1 00017, N1…Serial No.: N16E0 90002, N16E0 90003, N16E0 90004, N16E0 90007, N16E0 90008, N16E0 90010, N16E1 00015, N16E1 00017, N16E1 00023, N16E1 10016, N16E1 10023, N16E1 10026, N16E1 10027, N16E1 10040, and N16E1 10053. |
|---|
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-2083-2012%22
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