Neusoft Medical NeuViz 64 CT Scanner Software Defect Recall
Neusoft Medical Systems is recalling 234 NeuViz 64 CT scanners due to a software defect. The FDA mandated this recall for units distributed nationwide.
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. The source text does not report any hospitalizations, serious injuries, or deaths, and the hazard is a software defect without reported adverse health consequences, fitting the Moderate criteria for low-risk or precautionary issues.
Plain-English summary
Neusoft Medical Systems Co., Ltd. is recalling 234 units of the NeuViz 64 Multi-slice CT Scanner System. The affected models include the NeuViz 64e, NeuViz 64i, NeuViz 64En, and NeuViz 641n, specifically those running software version 1.0.6.3258 +P11 or previous, or version 1.0.7.4021+P11 or previous. These devices are used as whole-body computed tomography X-ray systems to create cross-sectional images of the body.
The recall was initiated on May 19, 2017, and mandated by the FDA due to a software defect. The agency classified this recall as Class II. The affected units were distributed nationwide in the United States. The recall was terminated on November 19, 2020.
Healthcare facilities and consumers should check their CT scanner models and software versions to determine if they are affected. If a unit is included in this recall, the manufacturer will provide instructions for remediation. The recall was initiated via letter notification to the initial firm.
The recalled product
- Product
- Neusoft Medical NeuViz 64 Multi-slice CT Scanner System, including: NeuViz 64e, NeuViz 64i with software version 1.0.6.3258 +P11 or previous version, NeuViz 64En, NeuViz 641n with software version 1.0.7.4021+P11 or previous version Product Usage: The Multi-Slice CT…
- Manufacturer
- Neusoft Medical Systems Co., Ltd.
- Hazard
- Affected units
- 234
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 (5)
- NeuViz 64 Multi-slice CT Scanner System
- including: NeuViz 64e
- NeuViz 64i with software version 1.0.6.3258 +P11 or previous version
- NeuViz 64En
- NeuViz 641n with software version 1.0.7.4021+P11 or previous version
Distribution
Distributed nationwide across the United States.
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
Same manufacturer · Neusoft Medical Systems Co., Ltd.
See all →- ModerateNeusoft NeuViz 64 CT Scanner Recalled for Image Loss Defect
FDA (Devices) · 2019-05-29
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- HighNeusoft NeuViz 128 CT Scanner Software Defect Recall
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- ModerateNeusoft NeuViz 64 CT Scanner Recall Due to Scan Interruption Error
FDA (Devices) · 2017-01-04
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Similar recalls
- ModerateNeusoft NeuViz 64 CT Scanner Recall Due to Scan Interruption Error
FDA (Devices) · 2017-01-04
- ModerateNeusoft NeuViz 64 CT Scanner Recalled for Image Loss Defect
FDA (Devices) · 2019-05-29
- ModerateNeusoft NeuViz 64 CT Scanner Software Icon Mismatch Recall
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- ModerateNeusoft NeuViz 128 CT Scanner Recalled for Software Defect
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- ModerateNeuViz 16 Essence CT Scanner Recalled for Software Defect
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- ModerateNeuViz 128 CT Scanner Software Recall for Scan Interruption Errors
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