Facility

NEUSOFT MEDICAL SYSTEMS CO., LTD.

4 recall(s) on record — most severe on record: Class II.

Key facts

4recalls · worst Class II

3inspections · worst VAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3003575350
Establishment type	Manufacture Medical Device
Location	No.177-1 Chuangxin Road SHENYANG Liaoning, CN 11016
Registration status	Active · expires 2026
Parent company	NEUSOFT MEDICAL SYSTEMS CO., LTD. (owner-operator 9050318)
Brand names	NeuViz 128

Activity by year

Recalls (4)
Inspections (3)

Devices registered here (1)

System, X-Ray, Tomography, Computed
Product code JAK (opens in a new tab) · Class II · Radiology · 21 CFR 892.1750

Recalls & enforcement

Class IITerminated2018-10-22
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 s…
Class IITerminated2017-05-19
Software defect
Class IITerminated2016-08-31
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.
Class IITerminated2015-05-02
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.

FDA inspections (3)

NAI2019-01-24
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices; Radiation Control and Health Safety Act
VAI2016-02-04
Voluntary Action Indicated · Compliance: Devices; Radiation Control and Health Safety Act; Postmarket Assurance: Devices · citations posted
VAI2016-01-29
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices; Radiation Control and Health Safety Act · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by NEUSOFT MEDICAL SYSTEMS CO., LTD.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “NEUSOFT MEDICAL SYSTEMS CO., LTD. (FEI 3003575350) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3003575350-neusoft-medical-systems-co-ltd/

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