# FDA recall Z-3044-2017

> **Neusoft Medical Systems Co., Ltd.** · Class II · device recall initiated 2017-05-19.

## Product

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.

## Reason for recall

Software defect

## Distribution

US Nationwide distribution

## Key facts

- **Recall number:** Z-3044-2017
- **Recalling firm:** Neusoft Medical Systems Co., Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-05-19
- **Report date:** 2017-09-06
- **Termination date:** 2020-11-19

- **Voluntary/Mandated:** FDA Mandated
- **Location:** Shenyang, N/A, China

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3044-2017

## Citation

> AI Analytics. FDA recall Z-3044-2017. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/Z-3044-2017. Source: US FDA. Licensed CC0.

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