Neusoft NeuViz 64 CT Scanner Recall Due to Scan Interruption Error
Neusoft Medical Systems is recalling 23 NeuViz 64 CT scanners because a software error may interrupt scans, requiring a system restart to resume.
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, injuries, or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Neusoft Medical Systems Co., Ltd. is recalling 23 units of the NeuViz 64 Multi-slice CT Scanner Systems. The recall affects specific software versions of the NeuViz 64e, NeuViz 64i, NeuViz 64En, and NeuViz 641n models.
The firm discovered that during a contrast agent tracking scan, the system may interrupt a later planned scan once the expected concentration of contrast agent is reached. To clear the interruption error and resume scanning, the system must be powered down and restarted.
This recall is classified as Class II by the FDA. No injuries or illnesses have been reported in the source text.
The recalled product
- Product
- NeuViz 64 Multi-slice CT Scanner Systems
- Manufacturer
- Neusoft Medical Systems Co., Ltd.
- Category
- Medical Device — CT Scanner
- Affected units
- 23
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 (2)
- NeuViz 64e
- NeuViz 641n with software version 1.0.7.4021+P05 or previous version
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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