Z-1281-2019Class II

NeuViz 16 Essence Multi-slice CT Scanner System

Name: Z-1281-2019 NeuViz 16 Essence Multi-slice CT Scanner System
Creator: Neusoft Medical Systems Co., Ltd.
Published: 2018-10-22
License: https://open.fda.gov/license/

Neusoft Medical Systems Co., Ltd. / initiated 2018-10-22 / Terminated / root cause: software

FDA source

Neusoft Medical Systems Co., Ltd. began a recall of NeuViz 16 Essence 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 2018-10-22. FDA classified it as Class II and gives the reason as "Software defect: For Helical scan with ClearView function, when small arc (uninterrupted scan) occurs during scan, there will be some electromagnetic interference in the system which may affect the control signal of 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-1281-2019
Classification: Class II
Status: Terminated
Initiated: 2018-10-22
Posted: 2019-05-21
Terminated: 2022-08-25
Recalling firm: Neusoft Medical Systems Co., Ltd.
Product: NeuViz 16 Essence 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: For Helical scan with ClearView function, when small arc (uninterrupted scan) occurs during scan, there will be some electromagnetic interference in the system which may affect the control signal of the flying focal spot, resulting in an incorrect flying focal spot sequence. If the system does not receive error, it would continue to complete the scan with the incorrect flying focal spot sequence, having an effect on the reconstruction of some images, resulting in image loss.
Root cause tag: software
FDA root cause: Software design
Action: A customer notification letter will be sent to affected customers by email. All the affected systems will be corrected with the upgraded software in the field free of charge.
Quantity in commerce: 2
Distribution: US Nationwide Distribution.
Product codes and lots: Series numbers N16E180037E; N16E180047E

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1281-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1279-2019	Class II	Terminated	FDA Mandated	2019-05-29	2019-05-21
Z-1280-2019	Class II	Terminated	FDA Mandated	2019-05-29	2019-05-21
Z-1281-2019	Class II	Terminated	FDA Mandated	2019-05-29	2019-05-21

Product code JAK

K171198Class IINeuViz 16 Essence Multi-slice CT Scanner SystemNeusoft Medical Systems Co., Ltd. / cleared 2017-12-07

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)