NeuViz 128 CT Scanner Recalled for Potential Image Field of View Error
Neusoft Medical Systems is recalling three NeuViz 128 CT scanners because a software defect may cause incorrect image field of view, potentially leading to misaligned clinical 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, but the source text does not report any hospitalizations or injuries. The hazard is a software defect leading to potential scan misalignment, which fits the criteria for a moderate severity recall involving a risk of harm where injury has not yet been reported or is theoretical.
Plain-English summary
Neusoft Medical Systems Imp & Ex is recalling three units of the NeuViz 128 Multi-slice CT Scanner System. The recall involves specific software versions and affects units distributed in Kansas, Oklahoma, and Massachusetts. The affected units have series numbers N1281180242E, N1281170231E, and N1281180248E.
The recall is due to a software defect that can occur when a user aborts or skips a reconstructed surview scan longer than 500mm. In these instances, the image may display the wrong field of view (FOV). If a user plans and performs a subsequent clinical scan using this incorrect FOV, the actual start and end positions of the scan may not match the planned positions.
Healthcare facilities that possess these specific units should contact the manufacturer for instructions on how to resolve the software issue. No injuries or illnesses have been reported in connection with this recall.
The recalled product
- Product
- NeuViz 128 Multi-slice CT Scanner System with software version 1.0.8.5010O+P04 Vi .0.8.521 9+PO1 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 tran
- Manufacturer
- NEUSOFT MEDICAL SYSTEMS IMP & EX
- Affected units
- 3
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 (3)
- Series number includes: N1281180242E
- N1281170231E
- N1281180248E
Distribution
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