FDAClass IIOctober 26, 2016

CADstream software Product Usage: CADstream is an image recall: Software Issue

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

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

Customers may experience an issue with the software study preferences when changes are made to the study protocol, resulting in incorrect patient follow-up.

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?

Versions prior to 5.2.6

Product
CADstream software Product Usage: CADstream is an image processing system designed to assist in the visualization, analysis, and reporting of magnetic…
Recalling firm
Merge Healthcare, Inc.
Quantity
844 sites potentially have the affected versions
Distribution
US Nationwide Distribution
Recall date
October 26, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls