Neusoft NeuViz 64 CT Scanner Software Icon Mismatch Recall
Neusoft Medical Systems is recalling seven NeuViz 64 CT scanners due to a software defect where side decubitus icons did not match the patient position description.
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, and the source text describes a software labeling mismatch without reporting any injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Neusoft Medical Systems Co., Ltd. is recalling seven units of the NeuViz 64 Multi-Slice CT Scanner System, including the NeuViz 64e and NeuViz 64i variants. The recall involves specific serial numbers: N64E120022E, N64E130039E, N64I130051E, N64E130062E, N64E130063E, N64E130066E, and N64I140077E.
The recall was initiated after the company's research and development team identified a defect in the NeuViz 64 system software version 1.0.5+P09 in April 2014. The defect caused the icons for side decubitus positions to not meet the patient position description when the scanner position was set to "Right" in the system settings.
The affected units were distributed in the United States, including Puerto Rico and the states of Illinois, Connecticut, South Carolina, and Nebraska. The source text does not specify the required corrective actions for consumers or healthcare facilities.
The recalled product
- Product
- NeuViz 64 Multi-Slice CT Scanner System (consist if two variants: NeuViz 64e, NeuViz 64i)
- Manufacturer
- Neusoft Medical Systems Co., Ltd.
- Affected units
- 7
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 (7)
- Serial Numbers: N64E120022E
- N64E130039E
- N64I130051E
- N64E130062E
- N64E130063E
- N64E130066E
- N64I140077E
Distribution
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