Recall Z-3044-2017— Neusoft Medical Systems Co., Ltd.
Class II · Terminated
Class II FDA medical device recall by Neusoft Medical Systems Co., Ltd., initiated 2017-05-19, terminated 2020-11-19. FDA's recall record names no specific 510(k) clearance for this event. 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: Software defect.
- Recalling firm
- Neusoft Medical Systems Co., Ltd.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-05-19
- Terminated
- 2020-11-19
- Firm location
- Shenyang, N/A, China
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.