FDA Medical Device Recalls (openFDA)
NEUSOFT MEDICAL SYSTEMS IMP & EX: NeuViz 128 Multi-slice CT Scanner System with software version 1.0.8.5010O+P04 Vi .0.8.521 9+PO1 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-0773-2019
- Recalling firm
- NEUSOFT MEDICAL SYSTEMS IMP & EX
- Product
- NeuViz 128 Multi-slice CT Scanner System with software version 1.0.8.5010O+P04 Vi .0.8.521 9+PO1 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
- 2019-01-09
- Posted
- not on file
- Terminated
- 2022-08-25
- Reason
- For surview scan length more than 500mm,if the user aborts or skips the reconstructed surview, the image may have the wrong field of view (FOV). When user plans and performs subsequent clinical scan with the wrong FOV the actual start and end position may not be consistent with the planned positons.
- Root cause
- Software design
- Action
- The firm, Neurosoft Medical Systems Co., Inc., issued a notice to its customers dated 11/26/2018. The notice described the product, problem and actions to be taken. The customers were instructed to do the following: Please plan surview length accurately according the clinical requirement, and not interrupt(abort or skip) scanning during the surview scan if the planning length is over 500mm. The defect will be remedied by updating software. Field Change Order related to software updated will be released to the affected systems in Jan, 2019. The affected systems will be upgraded with updated software in the field free of charge in 6 months after the FCO release. If you have any questions, contact Senior TQM Director at Tel: +86 024-2335831 1 or email: wangzq@neusoft.com.
- Quantity
- 3
- Distribution
- US Distribution in states of: KS, OK and MA.
- Lot, serial or model codes
- Series number includes: N1281180242E, N1281170231E, N1281180248E
- 510(k) numbers
- ["K151383"]
- PMA numbers
- not on file
- Product code
- JAK
- Firm FEI
- 3012245681
- Firm city
- Dongling 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