Reported May 18, 2016 · Terminated
NeuViz 64 Multi-Slice CT Scanner System (consist if two variants: NeuViz 64e, NeuViz 64i)
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 64 Multi-Slice CT
- Scanner System (consist if two variants
NeuViz 64eNeuViz 64i)
- Lot codes and dates
- Serial Numbers
N64E120022EN64E130039EN64I130051EN64E130062EN64E130063EN64E130066EN64I140077E
- Serial Numbers
- Amount recalled
- 7 units
Where it was sold
Why it was recalled
It was found by R&D in April, 2014 that there was a defect in NeuViz 64 system software version 1.0.5+P09. The icons of side decubitus didn't meet the patient position description, when the scanner position was set to "Right" in the system setting - scanner options.
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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