FDA recall Z-3044-2017

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

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

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