RegWardenFDA facility compliance records
Company

NEUSOFT MEDICAL SYSTEMS CO., LTD.

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

Recalls by year

FDA actions on record by year2015: 1 recalls; 2016: 1 recalls; 2017: 1 recalls; 2018: 1 recalls1201512016120171201820192020202120222023202420252026
  • Recalls (4)

Registered facilities (1)

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.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “NEUSOFT MEDICAL SYSTEMS CO., LTD. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-9050318-neusoft-medical-systems-co-ltd/

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