# FDA recall Z-0773-2019

> **NEUSOFT MEDICAL SYSTEMS IMP & EX** · Class II · device recall initiated 2019-01-09.

## Product

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.

## Reason for recall

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.

## Distribution

US Distribution in states of: KS, OK and MA.

## Key facts

- **Recall number:** Z-0773-2019
- **Recalling firm:** NEUSOFT MEDICAL SYSTEMS IMP & EX
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-01-09
- **Report date:** 2019-02-13
- **Termination date:** 2022-08-25

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0773-2019

## Citation

> AI Analytics. FDA recall Z-0773-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0773-2019. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*