NeuViz 128 Multi-slice CT Scanner System with software recall
NeuViz 128 Multi-slice CT Scanner System with software version 1.0.8.5010O+P04 Vi .0.8.521 9+PO1 Multi-Slice CT Scanner System can be used as a whole…
Why was NeuViz 128 Multi-slice CT Scanner System with software recalled?
For surview scan length more than 500mm,if the user aborts or skips the reconstructed surview, the image may have the wrong field of view (FOV). When user plans and performs subsequent clinical scan with the wrong FOV the actual start and end position may not be consistent with the planned positons.
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?
Series number includes: N1281180242E, N1281170231E, N1281180248E
- Product
- NeuViz 128 Multi-slice CT Scanner System with software version 1.0.8.5010O+P04 Vi .0.8.521 9+PO1 Multi-Slice CT Scanner System can be used as a whole…
- Recalling firm
- NEUSOFT MEDICAL SYSTEMS IMP & EX
- Quantity
- 3
- Distribution
- US Distribution in states of: KS, OK and MA.
- Recall date
- February 13, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)