NeuViz 16 Essence Multi-slice CT Scanner System 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.
Enforcement
- Recall Number
- Z-1281-2019
- Event ID
- 82753
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Neusoft Medical Systems Co., Ltd.
- Voluntary / Mandated
- FDA Mandated
- Initial Notification
- Letter
- Report Date
- May 29, 2019
- Initiation Date
- October 22, 2018
- Classification Date
- May 21, 2019
- Termination Date
- August 25, 2022
- Address
- No. 177-1 Cuangxin Road, Hunnan District, Shenyang, N/A, N/A, China
Description
NeuViz 16 Essence Multi-slice CT Scanner System 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: For Helical scan with ClearView function, when small arc (uninterrupted scan) occurs during scan, there will be some electromagnetic interference in the system which may affect the control signal of the flying focal spot, resulting in an incorrect flying focal spot sequence. If the system does not receive error, it would continue to complete the scan with the incorrect flying focal spot sequence, having an effect on the reconstruction of some images, resulting in image loss.
Series numbers N16E180037E; N16E180047E
US Nationwide Distribution.
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