Z-1650-2016Class II

NeuViz 64 Multi-Slice CT Scanner System (consist if two variants: NeuViz 64e, NeuViz 64i)

Name: Z-1650-2016 NeuViz 64 Multi-Slice CT Scanner System (consist if two variants: NeuViz 64e, NeuViz 64i)
Creator: Neusoft Medical Systems Co., Ltd.
Published: 2015-05-02
License: https://open.fda.gov/license/

Neusoft Medical Systems Co., Ltd. / initiated 2015-05-02 / Terminated / root cause: design

FDA source

Neusoft Medical Systems Co., Ltd. began a recall of NeuViz 64 Multi-Slice CT Scanner System (consist if two variants: NeuViz 64e, NeuViz 64i) on 2015-05-02. FDA classified it as Class II and gives the reason as "It was found by R&D in April, 2014 that there was a defect in NeuViz 64 system software version 1.0.5+P09. The icons of side decubitus didn't meet the patient position description, when the scanner position was set to...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1650-2016
Classification: Class II
Status: Terminated
Initiated: 2015-05-02
Posted: 2016-05-11
Terminated: 2016-11-04
Recalling firm: Neusoft Medical Systems Co., Ltd.
Product: NeuViz 64 Multi-Slice CT Scanner System (consist if two variants: NeuViz 64e, NeuViz 64i)
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: It was found by R&D in April, 2014 that there was a defect in NeuViz 64 system software version 1.0.5+P09. The icons of side decubitus didn't meet the patient position description, when the scanner position was set to "Right" in the system setting - scanner options.
Root cause tag: design
FDA root cause: Device Design
Action: An upgraded software version (1.0.5.2619+P11) was released on May 7, 2015. The FCO was released to the service engineers of Neusoft Medical Systems USA, which is subsidiary of the reporting firm, and the engineers performed FCO for each affected device together with the distributors' engineers. The corrections (FCOs to upgrade software) on all the affected systems in the USA have been completed. At present (4/27/16) there is no longer this issue on the systems, so no further actions are needed for customers/distributors. However, the recalling firm shall inform the direct accounts of this fix before May 5, 2016. The recalling firm will submit the communication evidence ASAP once they have evidence of the communication. For further questions, please call (281) 453-1205.
Quantity in commerce: 7 units
Distribution: US Distribution - Including Puerto Rico and the states of IL, CT, SC, NE
Product codes and lots: Serial Numbers: N64E120022E, N64E130039E, N64I130051E, N64E130062E, N64E130063E, N64E130066E, N64I140077E

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1650-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1650-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-18	2016-05-11

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)