FDAClass IISeptember 28, 2016

CADstream software. Product Usage: CADstream is an recall

CADstream software. Product Usage: CADstream is an image processing system designed to assist in the visualization, analysis, and reporting of…

Why was CADstream software. Product Usage: CADstream is an recalled?

An incorrect biopsy or missed target could result if the incorrect grid is selected within the application.

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?

All versions - Versions 4.1.3 and prior versions

Product
CADstream software. Product Usage: CADstream is an image processing system designed to assist in the visualization, analysis, and reporting of…
Recalling firm
Merge Healthcare, Inc.
Quantity
1,349 sites potentially have the affected versions
Distribution
US Nationwide Distribution
Recall date
September 28, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls