FDAClass IIMarch 22, 2017

Merge Hemo software. Product Usage: Merge Hemo is a recall

Merge Hemo software. Product Usage: Merge Hemo is a hemodynamic monitoring system that records and displays physiological data.

Why was Merge Hemo software. Product Usage: Merge Hemo is a recalled?

In some instances, the system will lock tabs within a study, even when a second user does not have the study open on a different workstation.

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 6.10, 6.10.1, 6.10.2, 6.10.3, 7.10, 7.20, 7.20.1, 8.10.0, 8.20, 9.10.0, 9.20, 9.20.2, 9.20.3, 9.30, 9.40, 9.40.1, 9.40.2, and 9.40.3

Product
Merge Hemo software. Product Usage: Merge Hemo is a hemodynamic monitoring system that records and displays physiological data.
Recalling firm
Merge Healthcare, Inc.
Quantity
361 sites potentially have the affected versions
Distribution
US Nationwide Distribution.
Recall date
March 22, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls