FDAClass IIDecember 21, 2016

Merge Cardio software. Merge Cardio is a system recall

Merge Cardio software. Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information from…

Why was Merge Cardio software. Merge Cardio is a system recalled?

Reporting feature times out after inactivity for more than an hour sending the user back to the study list, which causes all reporting data being entered to be lost.

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 V10.1 and 10.1.1

Product
Merge Cardio software. Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information from…
Recalling firm
Merge Healthcare, Inc.
Quantity
116 sites potentially have the effected versions
Distribution
Nationwide Distribution
Recall date
December 21, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls