FDAClass IISeptember 28, 2016

Merge Cardio software. Product Usage: Merge Cardio is recall

Merge Cardio software. Product Usage: Merge Cardio is an integrated cardiovascular information system classified as a picture archiving and…

Why was Merge Cardio software. Product Usage: Merge Cardio is recalled?

Patient information in the header is only found on the first page of the report and not on the subsequent pages.

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?

Version 10.1

Product
Merge Cardio software. Product Usage: Merge Cardio is an integrated cardiovascular information system classified as a picture archiving and…
Recalling firm
Merge Healthcare, Inc.
Quantity
42 sites potentially have the affected version
Distribution
US Nationwide Distribution
Recall date
September 28, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
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