Neusoft NeuViz 128 CT Scanner Recalled for Software Defect
Neusoft Medical Systems is recalling six NeuViz 128 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, but the hazard is limited to image loss due to a software defect without reports of patient injury or death, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Neusoft Medical Systems Co., Ltd. is recalling six units of the NeuViz 128 Multi-slice CT Scanner System. The recall is due to a software defect affecting the ClearView function during Helical scans. The affected units were distributed nationwide in the United States.
The defect involves electromagnetic interference that can occur during small arc scans. This interference may disrupt the control signal for the flying focal spot, leading to an incorrect sequence. If the system does not detect an error, it continues the scan with the incorrect sequence, which can result in the loss of some reconstructed images.
The recall covers six specific units with the following series numbers: N1281160084E, N1281160085E, N1281170161 E, N1281170231E, N1281180242E, and N1281180248E. Healthcare facilities should contact the manufacturer to arrange for the necessary software updates or repairs to resolve the issue.
The recalled product
- Product
- NeuViz 128 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 reconstructed by…
- Manufacturer
- Neusoft Medical Systems Co., Ltd.
- Affected units
- 6
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 (6)
- Series numbers N1281160084E
- N1281160085E
- N1281170161 E
- N1281170231E
- N1281180242E
- N1281180248E
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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