Manufacturer

Neusoft Medical Systems Co., Ltd.

8 recalls in our database name Neusoft Medical Systems Co., Ltd. as the manufacturing or recalling firm.

What the numbers show

Total: 8
Critical: 0
Severe: 0
Most recent: 2019-05-29

Of the 8 recalls from Neusoft Medical Systems Co., Ltd. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–8 of 8

ModerateFDA (Devices)·Z-1279-2019·2019-05-29
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.
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 comp
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1281-2019·2019-05-29
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.
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
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1280-2019·2019-05-29
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.
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 com
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3045-2017·2017-09-06
Neusoft NeuViz 128 CT Scanner Software Defect Recall
Neusoft Medical Systems is recalling 154 NeuViz 128 CT scanners due to a software defect. The FDA mandated this Class II recall for units distributed nationwide.
Product
Neusoft 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 reconstruc
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3044-2017·2017-09-06
Neusoft Medical NeuViz 64 CT Scanner Software Defect Recall
Neusoft Medical Systems is recalling 234 NeuViz 64 CT scanners due to a software defect. The FDA mandated this recall for units distributed nationwide.
Product
Neusoft Medical NeuViz 64 Multi-slice CT Scanner System, including: NeuViz 64e, NeuViz 64i with software version 1.0.6.3258 +P11 or previous version, NeuViz 64En, NeuViz 641n with software version 1.0.7.4021+P11 or previous version Product Usage: The Multi-Slice CT Sca
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0875-2017·2017-01-04
Neusoft NeuViz 64 CT Scanner Recall Due to Scan Interruption Error
Neusoft Medical Systems is recalling 23 NeuViz 64 CT scanners because a software error may interrupt scans, requiring a system restart to resume.
Product
NeuViz 64 Multi-slice CT Scanner Systems
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0876-2017·2017-01-04
NeuViz 128 CT Scanner Software Recall for Scan Interruption Errors
Neusoft Medical Systems is recalling 23 NeuViz 128 CT scanners due to software errors that interrupt scans during contrast agent tracking.
Product
NeuViz 128 Multi-slice CT Scanner System with software version 1.0.7.4038+P06 or previous version
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1650-2016·2016-05-18
Neusoft NeuViz 64 CT Scanner Software Icon Mismatch Recall
Neusoft Medical Systems is recalling seven NeuViz 64 CT scanners due to a software defect where side decubitus icons did not match the patient position description.
Product
NeuViz 64 Multi-Slice CT Scanner System (consist if two variants: NeuViz 64e, NeuViz 64i)
Category
Medical Device
Distribution
5 states