Neusoft Medical Systems Co., Ltd.: Software defect: For Helical scan with ClearView function, when small arc (uninterrupted scan) occurs during scan, there will be some electromagnetic interference in the system which may affect the control signal of the flying focal spot, resulting in an incorrect flying focal spot sequence. If the system does not receive error, it would continue to complete the scan with the incorrect flying focal spot sequence, having an effect on the reconstruction of some

Agency Publication Date: May 21, 2019

Affected Products

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 computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles.

N64E120022E; N64E130039E; N641130051 E; N64E130062E; N64E130063E; N64E130066E;1 N641140077E; N64E140116E; N641140117E; N641140118E; N641140119E; N641140120E; N64EN150043E; N64E150121E; N64E150125E; N641150129E; N641150131 E; N641150136E; N641N160066E; N641N160067E; N64EN160068E; N64EN160071 E; N64EN160082E; N64EN160085E; N64EN160086E; N641N1 70093E; N641N1701 05E; N641N1 701 16E; N641N170120E; N641N170127E; N641N170128E; N641N170129E; N641N180156E; N641N180157E; N641N180161E; N641N180162E; N641N180205E

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 computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles.

Series numbers N1281160084E; N1281160085E; N1281170161 E; N1281170231E; N1281180242E; N1281180248E

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 reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles.

Series numbers N16E180037E; N16E180047E

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 82753

Status: Resolved

Manufacturer: Neusoft Medical Systems Co., Ltd.

Manufactured In: China

Units Affected: 3 products (37; 6; 2)

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Sources: FDA iRES · Raw API Response

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Affected Products

Series numbers N1281160084E; N1281160085E; N1281170161 E; N1281170231E; N1281180242E; N1281180248E

Series numbers N16E180037E; N16E180047E