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.
Recall
- Recall Number
- Z-3044-2017
- Event Number
- 77608
- Firm
- Neusoft Medical Systems Co., Ltd. NO.
- FEI Number
- 3003575350
- Product Code
- JAK
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- May 19, 2017
- Terminated
- November 19, 2020
- Address
- 16 Shiji Road, Hunnan Industrial Area Shenyang China
Description
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.
Software defect
Neusoft Medical Systems will bring defect into compliance: The defect will be remedied by updating software. Field Change Order I related to software updated will be released to the affected systems in ' Aug, 2017. The affected systems will be upgraded with updated software in the field free of char e in 6 months after the FCO release.
US Nationwide distribution
234