NeuViz 16 Multi-Slice CT Scanner System is a computed Tomography… — Class II medical device recall Z-2083-2012

Terminated recall by Philips And Neusoft Medical Systems Co., Ltd., reported 2012-08-01, distributed nationwide. One of the four screws that secure the Oil-accumulator to the X-Ray Tube pulled out in the NeuViz 16 CT scanne

Recall number	`Z-2083-2012`
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	2012-06-08
Classified	2012-07-26
Reported by FDA	2012-08-01
Terminated	2012-09-17
Distributed	Nationwide (US)
Quantity	15 units
Reason classes	device malfunction
Serial numbers	`00015`, `00017`, `00023`, `10016`, `10023`, `10026`, `10027`, `10040`, `10053`, `90002`, `90003`, `90004`, `90007`, `90008`, `90010`, `N16E0`, `N16E1`
Model numbers	`989605858501`

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 for recall

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2083-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

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.