Neusoft NeuViz 64 CT Scanner Recalled for Image Loss Defect
Neusoft Medical Systems is recalling 37 NeuViz 64 CT scanners due to a software defect that can cause image loss during specific scans.
What this means for you
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. The hazard is a software defect resulting in image loss, which is a diagnostic quality issue rather than a direct physical injury or acute health risk, fitting the Moderate severity criteria for low-risk or precautionary issues without reported harm.
Plain-English summary
Neusoft Medical Systems Co., Ltd. is recalling 37 units of the NeuViz 64 Multi-slice CT Scanner System. The recall is due to a software defect affecting the ClearView function during Helical scans. The affected units were distributed nationwide in the United States.
The defect involves electromagnetic interference that can occur when a small arc (uninterrupted scan) happens during the scanning process. This interference may affect the control signal of the flying focal spot, leading to an incorrect sequence. If the system does not detect an error, it will continue the scan with the incorrect sequence, which can result in the loss of some reconstructed images.
Healthcare facilities and users of the NeuViz 64 Multi-slice CT Scanner System should contact Neusoft Medical Systems Co., Ltd. for instructions on how to resolve the software defect. The recall is limited to the specific serial numbers listed in the agency's official documentation.
The recalled product
- Product
- NeuViz 64 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 comp
- Manufacturer
- Neusoft Medical Systems Co., Ltd.
- Affected units
- 37
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 (20)
- N64E120022E
- N64E130039E
- N641130051 E
- N64E130062E
- N64E130063E
- N64E130066E
- 1 N641140077E
- N64E140116E
- N641140117E
- N641140118E
- N641140119E
- N641140120E
- N64EN150043E
- N64E150121E
- N64E150125E
- N641150129E
- N641150131 E
- N641150136E
- N641N160066E
- N641N160067E
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Neusoft Medical Systems Co., Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Neusoft Medical Systems Co., Ltd.
See all →- ModerateNeusoft NeuViz 128 CT Scanner Recalled for Software Defect
FDA (Devices) · 2019-05-29
- ModerateNeuViz 16 Essence CT Scanner Recalled for Software Defect
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- ModerateNeusoft Medical NeuViz 64 CT Scanner Software Defect Recall
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- HighNeusoft NeuViz 128 CT Scanner Software Defect Recall
FDA (Devices) · 2017-09-06
- ModerateNeusoft NeuViz 64 CT Scanner Recall Due to Scan Interruption Error
FDA (Devices) · 2017-01-04
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