Z-3045-2017Class II

Neusoft NeuViz 128 Multi-slice CT Scanner System

Name: Z-3045-2017 Neusoft NeuViz 128 Multi-slice CT Scanner System
Creator: Neusoft Medical Systems Co., Ltd.
Published: 2017-05-19
License: https://open.fda.gov/license/

Neusoft Medical Systems Co., Ltd. / initiated 2017-05-19 / Terminated / root cause: software

FDA source

Neusoft Medical Systems Co., Ltd. began a recall of Neusoft NeuViz 128 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray system... on 2017-05-19. FDA classified it as Class II and gives the reason as "Software defect". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-3045-2017
Classification: Class II
Status: Terminated
Initiated: 2017-05-19
Posted: 2017-08-28
Terminated: 2020-11-19
Recalling firm: Neusoft Medical Systems Co., Ltd.
Product: Neusoft NeuViz 128 Multi-slice CT Scanner System Product Usage: The Multi-Slice 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. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Software defect
Root cause tag: software
FDA root cause: Software design
Action: Neusoft Medical Systems will bring defect into compliance: The defect will be remedied by updating software. Field Change Order I related to software updated will be released to the affected systems in ' Aug, 2017. The affected systems will be upgraded with updated software in the field free of char e in 6 months after the FCO release.
Quantity in commerce: 154
Distribution: US Nationwide distribution
Product codes and lots: NeuViz 128 Multi-slice CT Scanner System with software version 1.0.7.4038+P16 or previous version

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3045-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3044-2017	Class II	Terminated	FDA Mandated	2017-09-06	2017-08-28
Z-3045-2017	Class II	Terminated	FDA Mandated	2017-09-06	2017-08-28

Product code JAK

K151383Class IINeuViz 128 Multi-slice CT Scanner SystemNeusoft Medical Systems Co., Ltd. / cleared 2015-11-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)