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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls without specific reports of hospitalization or structural defects fall into the High severity category, representing a risk of harm where injury has not yet been reported or is remote.
Plain-English summary
Neusoft Medical Systems Co., Ltd. is recalling 154 units of the NeuViz 128 Multi-slice CT Scanner System. These devices are used as whole-body computed tomography X-ray systems that reconstruct cross-sectional images of the body. The recall covers systems equipped with software version 1.0.7.4038+P16 or any previous version.
The recall was initiated on May 19, 2017, and was mandated by the FDA. The reason for the recall is a software defect. The agency classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
The affected units were distributed nationwide in the United States. The recall status is currently terminated, with a termination date of November 19, 2020. Initial notification to facilities was sent via letter.
The recalled product
- 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
- Manufacturer
- Neusoft Medical Systems Co., Ltd.
- Hazard
- Affected units
- 154
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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 2 products in this recall →Related recalls
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