FDA Medical Device Recalls (openFDA)
Neusoft Medical Systems Co., Ltd.: Neusoft 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-3045-2017
- Recalling firm
- Neusoft Medical Systems Co., Ltd.
- Product
- Neusoft 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
- 2017-05-19
- Posted
- not on file
- Terminated
- 2020-11-19
- Reason
- Software defect
- Root cause
- Software design
- Action
- 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.
- Quantity
- 154
- Distribution
- US Nationwide distribution
- Lot, serial or model codes
- NeuViz 128 Multi-slice CT Scanner System with software version 1.0.7.4038+P16 or previous version
- 510(k) numbers
- ["K151383"]
- PMA numbers
- not on file
- Product code
- JAK
- Firm FEI
- 3003575350
- Firm city
- Shenyang
- 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