Reported Jan 4, 2017 · Terminated
NeuViz 128 Multi-slice CT Scanner System with software version 1.0.7.4038+P06 or previous version
Neusoft Medical Systems Co., Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Neusoft Medical Systems Co., Ltd. · NO. 16 Shiji Road · Shenyang, N/A · N/A
Is this the product you have?
- NeuViz 128 Multi-slice CT Scanner System with software version 1.0.7.4038+P06 or previous version
- Lot codes and dates
- NeuViz 128 Multi-slice CT Scanner System with software version 1.0.7.4038+P06 or previous version
- Amount recalled
- 23 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Why it was recalled
The Firm discovered during contrast agent tracking scan, when the expected concentration of contrast agent is reached, later planned scan may be interrupted. The system must be powered down and restarted to clear the interruption error before scanning can resume.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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