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Neusoft Medical Systems Recalls
8 recalls on record · May 18, 2016 to May 29, 2019 · Medical Devices
Recalls by year
16
17
19
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
May 29, 2019Medical DevicesFDA
Neusoft Medical Systems Co., Ltd. recalls NeuViz 16 Essence Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner System can be used as a who
Hazard: 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 images, resulting in image loss.
May 29, 2019Medical DevicesFDA
Neusoft Medical Systems Co., Ltd. recalls NeuViz 128 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner System can be used as a whole body
Hazard: 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 images, resulting in image loss.
May 29, 2019Medical DevicesFDA
Neusoft Medical Systems Co., Ltd. recalls NeuViz 64 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner System can be used as a whole body
Hazard: 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 images, resulting in image loss.
September 6, 2017Medical DevicesFDA
Neusoft Medical Systems Co., Ltd. recalls Neusoft NeuViz 128 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner System can be used as a
Hazard: Software defect
September 6, 2017Medical DevicesFDA
Neusoft Medical Systems Co., Ltd. recalls Neusoft Medical NeuViz 64 Multi-slice CT Scanner System, including: NeuViz 64e, NeuViz 64i with software version 1
Hazard: Software defect
January 4, 2017Medical DevicesFDA
Neusoft Medical Systems Co., Ltd. recalls NeuViz 128 Multi-slice CT Scanner System with software version 1.0.7.4038+P06 or previous version
Hazard: The Firm discovered during contrast agent tracking scan, when the expected concentration of contrast agent is reached, later planned scan may be interrupted. The system must be powered down and restarted to clear the interruption error before scanning can resume.
January 4, 2017Medical DevicesFDA
Neusoft Medical Systems Co., Ltd. recalls NeuViz 64 Multi-slice CT Scanner Systems
Hazard: The Firm discovered during contrast agent tracking scan, when the expected concentration of contrast agent is reached, later planned scan may be interrupted. The system must be powered down and restarted to clear the interruption error before scanning can resume.
May 18, 2016Medical DevicesFDA
Neusoft Medical Systems Co., Ltd. recalls NeuViz 64 Multi-Slice CT Scanner System (consist if two variants: NeuViz 64e, NeuViz 64i)
Hazard: It was found by R&D in April, 2014 that there was a defect in NeuViz 64 system software version 1.0.5+P09. The icons of side decubitus didn't meet the patient position description, when the scanner position was set to "Right" in the system setting - scanner options.