FDA Medical Device Recalls (openFDA)
Neusoft Medical Systems Co., Ltd.: NeuViz 128 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.
- Recall number
- Z-1280-2019
- Recalling firm
- Neusoft Medical Systems Co., Ltd.
- Product
- NeuViz 128 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.
- Status
- Terminated
- Initiated
- 2018-10-22
- Posted
- not on file
- Terminated
- 2022-08-25
- Reason
- 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.
- Root cause
- Software design
- Action
- A customer notification letter will be sent to affected customers by email. All the affected systems will be corrected with the upgraded software in the field free of charge.
- Quantity
- 6
- Distribution
- US Nationwide Distribution.
- Lot, serial or model codes
- Series numbers N1281160084E; N1281160085E; N1281170161 E; N1281170231E; N1281180242E; N1281180248E
- 510(k) numbers
- ["K151383"]
- PMA numbers
- not on file
- Product code
- JAK
- Firm FEI
- 3003575350
- Firm city
- Shenyang Hunnan District
- Firm state
- not on file
- Firm country
- China
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28