Z-0875-2017Class II

NeuViz 64 Multi-slice CT Scanner Systems

Name: Z-0875-2017 NeuViz 64 Multi-slice CT Scanner Systems
Creator: Neusoft Medical Systems Co., Ltd.
Published: 2016-08-31
License: https://open.fda.gov/license/

Neusoft Medical Systems Co., Ltd. / initiated 2016-08-31 / Terminated / root cause: software

FDA source

Neusoft Medical Systems Co., Ltd. began a recall of NeuViz 64 Multi-slice CT Scanner Systems on 2016-08-31. FDA classified it as Class II and gives the reason as "The Firm discovered during contrast agent tracking scan, when the expected concentration of contrast agent is reached, later planned scan may be interrupted. The system must be powered down and restarted to clear the...". 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-0875-2017
Classification: Class II
Status: Terminated
Initiated: 2016-08-31
Posted: 2016-12-23
Terminated: 2018-01-04
Recalling firm: Neusoft Medical Systems Co., Ltd.
Product: NeuViz 64 Multi-slice CT Scanner Systems
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: The Firm discovered during contrast agent tracking scan, when the expected concentration of contrast agent is reached, later planned scan may be interrupted. The system must be powered down and restarted to clear the interruption error before scanning can resume.
Root cause tag: software
FDA root cause: Software design
Action: Neusoft Medical Systems Co. Ltd. planned action to bring into compliance. 1.Affected Customers will be notified by letter to provide them a description of the affected device, instructions for using the device prior to correction, hazards associated with the defect, and a statement of corrective actions to be taken at no cost to the owner. 2.Field Service Engineers will visit owner sites to install a software update which resolves the defect. 3.Corrections will be made at no cost to the owner 4.Corrections will be completed by May 11, 2017. CDRH approves the CAP subject to the following conditions: .Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. Further questions please call (281) 453-1205.
Quantity in commerce: 23 units
Distribution: US Distribution
Product codes and lots: NeuViz 64e, NeuViz 64i with software version 1.0.6.3258 +P04 or previous version. NeuViz 64En, NeuViz 641n with software version 1.0.7.4021+P05 or previous version

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0875-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0875-2017	Class II	Terminated	FDA Mandated	2017-01-04	2016-12-23
Z-0876-2017	Class II	Terminated	FDA Mandated	2017-01-04	2016-12-23

Product code JAK

K121792Class IINeuviz 64 Multi-Slice CT Scanner SystemNeusoft Medical Systems Co., Ltd. / cleared 2012-11-16

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)