Z-0773-2019Class II

NeuViz 128 Multi-slice CT Scanner System with software version 1.0.8.5010O+P04 Vi .0.8.521 9+PO1 Multi-Slice...

Name: Z-0773-2019 NeuViz 128 Multi-slice CT Scanner System with software version 1.0.8.5010O+P04 Vi .0.8.521 9+PO1 Multi-Slice...
Creator: Neusoft Medical Systems Imp & Ex
Published: 2019-01-09
License: https://open.fda.gov/license/

Neusoft Medical Systems Imp & EX / initiated 2019-01-09 / Terminated / root cause: software

FDA source

NEUSOFT MEDICAL SYSTEMS IMP & EX began a recall of NeuViz 128 Multi-slice CT Scanner System with software version 1.0.8.5010O+P04 Vi .0.8.521 9+PO1 Multi-Slice CT Scanner System can be used as a whole body... on 2019-01-09. FDA classified it as Class II and gives the reason as "For surview scan length more than 500mm,if the user aborts or skips the reconstructed surview, the image may have the wrong field of view (FOV). When user plans and performs subsequent clinical scan with the wrong FOV...". 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-0773-2019
Classification: Class II
Status: Terminated
Initiated: 2019-01-09
Posted: 2019-02-05
Terminated: 2022-08-25
Recalling firm: Neusoft Medical Systems Imp & EX
Product: NeuViz 128 Multi-slice CT Scanner System with software version 1.0.8.5010O+P04 Vi .0.8.521 9+PO1 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: For surview scan length more than 500mm,if the user aborts or skips the reconstructed surview, the image may have the wrong field of view (FOV). When user plans and performs subsequent clinical scan with the wrong FOV the actual start and end position may not be consistent with the planned positons.
Root cause tag: software
FDA root cause: Software design
Action: The firm, Neurosoft Medical Systems Co., Inc., issued a notice to its customers dated 11/26/2018. The notice described the product, problem and actions to be taken. The customers were instructed to do the following: Please plan surview length accurately according the clinical requirement, and not interrupt(abort or skip) scanning during the surview scan if the planning length is over 500mm. The defect will be remedied by updating software. Field Change Order related to software updated will be released to the affected systems in Jan, 2019. The affected systems will be upgraded with updated software in the field free of charge in 6 months after the FCO release. If you have any questions, contact Senior TQM Director at Tel: +86 024-2335831 1 or email: [email protected].
Quantity in commerce: 3
Distribution: US Distribution in states of: KS, OK and MA.
Product codes and lots: Series number includes: N1281180242E, N1281170231E, N1281180248E

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0773-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0773-2019	Class II	Terminated	FDA Mandated	2019-02-13	2019-02-05

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)