NeuViz 128 CT Scanner Recalled for Potential Image Field of View Error
Neusoft Medical Systems is recalling three NeuViz 128 CT scanners because a software defect may cause incorrect image field of view, potentially leading to misaligned clinical scans.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations or injuries. The hazard is a software defect leading to potential scan misalignment, which fits the criteria for a moderate severity recall involving a risk of harm where injury has not yet been reported or is theoretical.
Plain-English summary
Neusoft Medical Systems Imp & Ex is recalling three units of the NeuViz 128 Multi-slice CT Scanner System. The recall involves specific software versions and affects units distributed in Kansas, Oklahoma, and Massachusetts. The affected units have series numbers N1281180242E, N1281170231E, and N1281180248E.
The recall is due to a software defect that can occur when a user aborts or skips a reconstructed surview scan longer than 500mm. In these instances, the image may display the wrong field of view (FOV). If a user plans and performs a subsequent clinical scan using this incorrect FOV, the actual start and end positions of the scan may not match the planned positions.
Healthcare facilities that possess these specific units should contact the manufacturer for instructions on how to resolve the software issue. No injuries or illnesses have been reported in connection with this recall.
The recalled product
- 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…
- Manufacturer
- NEUSOFT MEDICAL SYSTEMS IMP & EX
- Affected units
- 3
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Series number includes: N1281180242E
- N1281170231E
- N1281180248E
Distribution
Related recalls
Same hazard · software defect
See all →- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- HighPhilips Spectral CT Systems Recalled for Software Issues Affecting Safety
FDA (Devices) · 2026-10-14
- ModerateSteris HexaVue Focus Integration System Recalled for Patient Data Mismatch
FDA (Devices) · 2026-10-14
- ModerateUnited Imaging uMI Panvivo S PET/CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
- ModerateUnited Imaging uCT 550 CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
Similar recalls
- ModerateNeusoft NeuViz 128 CT Scanner Recalled for Software Defect
FDA (Devices) · 2019-05-29
- HighNeusoft NeuViz 128 CT Scanner Software Defect Recall
FDA (Devices) · 2017-09-06
- ModerateNeusoft NeuViz 64 CT Scanner Recalled for Image Loss Defect
FDA (Devices) · 2019-05-29
- ModerateNeuViz 128 CT Scanner Software Recall for Scan Interruption Errors
FDA (Devices) · 2017-01-04
- ModerateNeuViz 16 Essence CT Scanner Recalled for Software Defect
FDA (Devices) · 2019-05-29
- ModerateNeusoft NeuViz 64 CT Scanner Recall Due to Scan Interruption Error
FDA (Devices) · 2017-01-04