NeuViz 128 Multi-slice CT Scanner System with software recall
NeuViz 128 Multi-slice CT Scanner System with software version 1.0.7.4038+P06 or previous version
Why was NeuViz 128 Multi-slice CT Scanner System with software 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
NeuViz 128 Multi-slice CT Scanner System with software version 1.0.7.4038+P06 or previous version
- Product
- NeuViz 128 Multi-slice CT Scanner System with software version 1.0.7.4038+P06 or previous version
- Recalling firm
- Neusoft Medical Systems Co., Ltd.
- Quantity
- 23 units
- Distribution
- US Distribution
- Recall date
- January 4, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)