Neusoft Medical Systems Co., Ltd.
Complete recall history across all FDA and CPSC categories — 8 total recalls
Neusoft Medical Systems Co., Ltd. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (8)
FDA medical device enforcement actions by Neusoft Medical Systems Co., Ltd.
| Date | Product | Reason | Class |
|---|---|---|---|
| Oct 22, 2018 | NeuViz 128 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT... | Software defect: For Helical scan with ClearView function, when small arc (un... | Class II |
| Oct 22, 2018 | NeuViz 16 Essence Multi-slice CT Scanner System Product Usage: The Multi-S... | Software defect: For Helical scan with ClearView function, when small arc (un... | Class II |
| Oct 22, 2018 | NeuViz 64 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT ... | Software defect: For Helical scan with ClearView function, when small arc (un... | Class II |
| May 19, 2017 | Neusoft NeuViz 128 Multi-slice CT Scanner System Product Usage: The Mul... | Software defect | Class II |
| May 19, 2017 | Neusoft Medical NeuViz 64 Multi-slice CT Scanner System, including: Neu... | Software defect | Class II |
| Aug 31, 2016 | NeuViz 128 Multi-slice CT Scanner System with software version 1.0.7.4038+P0... | The Firm discovered during contrast agent tracking scan, when the expected co... | Class II |
| Aug 31, 2016 | NeuViz 64 Multi-slice CT Scanner Systems | The Firm discovered during contrast agent tracking scan, when the expected co... | Class II |
| May 2, 2015 | NeuViz 64 Multi-Slice CT Scanner System (consist if two variants: NeuViz 64e,... | It was found by R&D in April, 2014 that there was a defect in NeuViz 64 syste... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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