NeuViz 64 Multi-slice CT Scanner Systems recall
NeuViz 64 Multi-slice CT Scanner Systems
Why was NeuViz 64 Multi-slice CT Scanner Systems 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 64e, NeuViz 64i with software version 1.0.6.3258 +P04 or previous version. NeuViz 64En, NeuViz 641n with software version 1.0.7.4021+P05 or previous version
- Product
- NeuViz 64 Multi-slice CT Scanner Systems
- 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)