Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1279-2019·Announced 2019-05-29

Neusoft NeuViz 64 CT Scanner Recalled for Image Loss Defect

Neusoft Medical Systems is recalling 37 NeuViz 64 CT scanners due to a software defect that can 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 is a software defect resulting in image loss, which is a diagnostic quality issue rather than a direct physical injury or acute health risk, fitting the Moderate severity criteria for low-risk or precautionary issues without reported harm.

Plain-English summary

Neusoft Medical Systems Co., Ltd. is recalling 37 units of the NeuViz 64 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 when a small arc (uninterrupted scan) happens during the scanning process. This interference may affect the control signal of the flying focal spot, leading to an incorrect sequence. If the system does not detect an error, it will continue the scan with the incorrect sequence, which can result in the loss of some reconstructed images.

Healthcare facilities and users of the NeuViz 64 Multi-slice CT Scanner System should contact Neusoft Medical Systems Co., Ltd. for instructions on how to resolve the software defect. The recall is limited to the specific serial numbers listed in the agency's official documentation.

The recalled product

Product: NeuViz 64 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.
Category: Medical Device — Imaging Equipment
Hazard: software-defect
image-loss
Affected units: 37

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 (20)

N64E120022E
N64E130039E
N641130051 E
N64E130062E
N64E130063E
N64E130066E
1 N641140077E
N64E140116E
N641140117E
N641140118E
N641140119E
N641140120E
N64EN150043E
N64E150121E
N64E150125E
N641150129E
N641150131 E
N641150136E
N641N160066E
N641N160067E

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.

See all 3 products in this recall →

Same manufacturer · Neusoft Medical Systems Co., Ltd.

See all →

Moderate
Neusoft NeuViz 128 CT Scanner Recalled for Software Defect
FDA (Devices) · 2019-05-29
Moderate
NeuViz 16 Essence CT Scanner Recalled for Software Defect
FDA (Devices) · 2019-05-29
Moderate
Neusoft Medical NeuViz 64 CT Scanner Software Defect Recall
FDA (Devices) · 2017-09-06
High
Neusoft NeuViz 128 CT Scanner Software Defect Recall
FDA (Devices) · 2017-09-06
Moderate
Neusoft NeuViz 64 CT Scanner Recall Due to Scan Interruption Error
FDA (Devices) · 2017-01-04

Same hazard · software defect