Z-3044-2017 Class II Terminated
FDA device recall Z-3044-2017 was initiated by Neusoft Medical Systems Co., Ltd. on May 19, 2017 and is designated Class II. Reason for recall: Software defect The recall status is terminated (terminated November 19, 2020). Affected quantity: 234.
Recall Details
- Product Type
- Devices
- Report Date
- September 6, 2017
- Initiation Date
- May 19, 2017
- Termination Date
- November 19, 2020
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 234
Product 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.
Reason for Recall
Software defect
Distribution Pattern
US Nationwide distribution
Code Information
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