Food, drugs, devices › Neusoft Medical Systems Co., Ltd.
Device recall: Neusoft Medical NeuViz 64 Multi-slice CT Scanner System, including: NeuViz 64e, NeuViz 64i with software version 1.0.6.3
FDA enforcement event 77608 is a device recall by Neusoft Medical Systems Co., Ltd. of Shenyang, N/A, initiated 19 May 2017 and classified Class II, with 2 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 93% of the 1,091 device enforcement events initiated in 2017 carry the same class.
Status: Terminated, terminated 19 Nov 2020. Initiation: fda mandated. Neusoft Medical Systems Co., Ltd. has 4 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Neusoft Medical Systems Co., Ltd., Shenyang, N/A, China.
Reason for recall
"Software defect"
Distribution
"US Nationwide distribution"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-3044-2017 | 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 Scanner System can be used as a whole body computed… | 234 | Class II | Terminated | 6 Sep 2017 |
| Z-3045-2017 | 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 reconstructed by computer into cross-sectional images… | 154 | Class II | Terminated | 6 Sep 2017 |
Context
Other enforcement events for Neusoft Medical Systems Co., Ltd.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 22 Oct 2018 | NeuViz 64 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner System can be used as a whole body com | Device | Class II | 3 |
| 31 Aug 2016 | NeuViz 64 Multi-slice CT Scanner Systems | Device | Class II | 2 |
| 2 May 2015 | NeuViz 64 Multi-Slice CT Scanner System (consist if two variants: NeuViz 64e, NeuViz 64i) | Device | Class II | 1 |
All 4 events for Neusoft Medical Systems Co., Ltd.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Software defect"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide distribution"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 19 Nov 2020. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.