NeuViz 128 CT Scanner Software Recall for Scan Interruption Errors
Neusoft Medical Systems is recalling 23 NeuViz 128 CT scanners due to software errors that interrupt scans during contrast agent tracking.
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 describes a software interruption error requiring a restart rather than a direct physical hazard or reported injury, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Neusoft Medical Systems Co., Ltd. is recalling 23 units of the NeuViz 128 Multi-slice CT Scanner System. The recall affects systems running software version 1.0.7.4038+P06 or any previous version. These units were distributed in the United States.
The firm identified a software defect during contrast agent tracking scans. When the expected concentration of the contrast agent is reached, the system may interrupt the planned scan. To clear the interruption error and resume scanning, the system must be powered down and restarted.
No specific instructions for consumers are provided in the source text, as this is a medical device recall managed by the manufacturer and healthcare facilities.
The recalled product
- Product
- NeuViz 128 Multi-slice CT Scanner System with software version 1.0.7.4038+P06 or previous version
- Manufacturer
- Neusoft Medical Systems Co., Ltd.
- Category
- Medical Device — CT Scanner
- Affected units
- 23
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 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 2 products in this recall →Related recalls
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