NeuViz 16 Essence CT Scanner Recalled for Software Defect
Neusoft Medical Systems is recalling two NeuViz 16 Essence CT scanners due to a software defect that may cause image loss during specific scans.
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 hazard involves potential image loss due to a software defect, which is a functional issue rather than a direct physical injury or high-risk pathogen exposure, fitting the Moderate category for low-risk technical defects.
Plain-English summary
Neusoft Medical Systems Co., Ltd. is recalling two units of the NeuViz 16 Essence Multi-slice CT Scanner System. The affected units have series numbers N16E180037E and N16E180047E and were distributed nationwide in the United States.
The recall is due to a software defect affecting Helical scans with the ClearView function. If a small arc (uninterrupted scan) occurs, electromagnetic interference may disrupt the control signal for the flying focal spot. This can result in an incorrect flying focal spot sequence, which may cause image loss during reconstruction if the system does not detect the error.
Healthcare facilities should contact Neusoft Medical Systems for instructions on how to address the software defect.
The recalled product
- Product
- NeuViz 16 Essence Multi-slice CT Scanner System Product Usage: The 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 transmission data is…
- Manufacturer
- Neusoft Medical Systems Co., Ltd.
- Affected units
- 2
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)
- Series numbers N16E180037E
- N16E180047E
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 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.
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