Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

NeuViz 128 Multi-slice CT Scanner System with software version 1.0.7.4038+P06 Recalled by Neusoft Medical Systems Co., Ltd. Due to The Firm discovered during contrast agent tracking scan,...

Date: August 31, 2016
Company: Neusoft Medical Systems Co., Ltd.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Neusoft Medical Systems Co., Ltd. directly.

Affected Products

NeuViz 128 Multi-slice CT Scanner System with software version 1.0.7.4038+P06 or previous version

Quantity: 23 units

Why Was This Recalled?

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.

Where Was This Sold?

US Distribution

About Neusoft Medical Systems Co., Ltd.

Neusoft Medical Systems Co., Ltd. has 8 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report