FDAClass IISeptember 7, 2016

Merge Cardio software. The firm name on the label is recall

Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Image processing system.

Why was Merge Cardio software. The firm name on the label is recalled?

A report can be confirmed with the incorrect patient demographics resulting in it being saved under the incorrect patient record in the Electronic Medical Record (EMR).

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 10.1 and 10.1.1

Product
Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Image processing system.
Recalling firm
Merge Healthcare, Inc.
Quantity
116 customers potentially have the affected versions
Distribution
Nationwide Distribution
Recall date
September 7, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls