Class II — Potential Health Hazard

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

Neusoft Medical NeuViz 64 Multi-slice CT Scanner System Recalled by Neusoft Medical Systems Co., Ltd. Due to Software defect

Date: May 19, 2017
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

Neusoft Medical NeuViz 64 Multi-slice CT Scanner System, including: NeuViz 64e, NeuViz 64i with software version 1.0.6.3258 +P11 or previous version, NeuViz 64En, NeuViz 641n with software version 1.0.7.4021+P11 or previous version 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.

Quantity: 234

Why Was This Recalled?

Software defect

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

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