CLASS II Device recall · Reported 6 Sep 2017 · FDA Enforcement Report
Neusoft NeuViz 128 Multi-slice CT Scanner System recalled
Neusoft Medical Systems Co is recalling Neusoft NeuViz 128 Multi-slice CT Scanner System, distributed nationwide in the US. The recall was initiated on 19 May 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-3045-2017
- FDA event ID
- 77608
- Recalling firm
- Neusoft Medical Systems Co, Shenyang, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 May 2017
- FDA classified
- 28 Aug 2017
- Reported
- 6 Sep 2017
- Type
- FDA Mandated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Imaging Equipment
Timeline
| 19 May 2017 | Recall initiated by company | |
| 28 Aug 2017 | Classified by FDA | +101 days |
| 6 Sep 2017 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Software defect
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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 of the body from either the same axial plane taken at different angles or spiral planes taken at different angles.
Where it was distributed
US Nationwide distribution
Questions about this recall
Is Neusoft NeuViz 128 Multi-slice CT Scanner System recalled?
Yes. Neusoft Medical Systems Co recalled Neusoft NeuViz 128 Multi-slice CT Scanner System on 19 May 2017. The recall is Class II and its status is Terminated. Recall number Z-3045-2017.
Why was it recalled?
Software defect
Which lots are affected?
NeuViz 128 Multi-slice CT Scanner System with software version 1.0.7.4038+P16 or previous version
Where was it sold?
US Nationwide distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Neusoft Medical Systems Co
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | NeuViz 128 Multi-slice CT Scanner System recalled | Neusoft Medical Systems Co | Device Malfunction | Nationwide |
| Device | CLASS II | NeuViz 16 Essence Multi-slice CT Scanner System recalled | Neusoft Medical Systems Co | Device Malfunction | Nationwide |
| Device | CLASS II | NeuViz 64 Multi-slice CT Scanner System recalled | Neusoft Medical Systems Co | Device Malfunction | Nationwide |
| Device | CLASS II | Neusoft Medical NeuViz 64 Multi-slice CT Scanner System recalled | Neusoft Medical Systems Co | Device Malfunction | Nationwide |
| Device | CLASS II | NeuViz 128 Multi-slice CT Scanner System recalled | Neusoft Medical Systems Co | Device Malfunction | N/A |
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