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 1.0.8.5010O+P04 Recalled by NEUSOFT MEDICAL SYSTEMS IMP & EX Due to For surview scan length more than 500mm,if the...

Date: January 9, 2019
Company: NEUSOFT MEDICAL SYSTEMS IMP & EX
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 IMP & EX directly.

Affected Products

NeuViz 128 Multi-slice CT Scanner System with software version 1.0.8.5010O+P04 Vi .0.8.521 9+PO1 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: 3

Why Was This Recalled?

For surview scan length more than 500mm,if the user aborts or skips the reconstructed surview, the image may have the wrong field of view (FOV). When user plans and performs subsequent clinical scan with the wrong FOV the actual start and end position may not be consistent with the planned positons.

Where Was This Sold?

This product was distributed to 3 states: KS, MA, OK

Affected (3 states)Not affected

About NEUSOFT MEDICAL SYSTEMS IMP & EX

NEUSOFT MEDICAL SYSTEMS IMP & EX has 1 total recall tracked by RecallDetector.

Related Recalls

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