FDAClass IISeptember 6, 2017

Neusoft NeuViz 128 Multi-slice CT Scanner System recall: Software Issue

Neusoft NeuViz 128 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner System can be used as a whole body computed tomography…

Why was Neusoft NeuViz 128 Multi-slice CT Scanner System recalled?

Software defect

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+P16 or previous version

Product
Neusoft NeuViz 128 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner System can be used as a whole body computed tomography…
Recalling firm
Neusoft Medical Systems Co., Ltd.
Quantity
154
Distribution
US Nationwide distribution
Recall date
September 6, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
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