Z-1457-2017Class II

Merge Hemo software

Name: Z-1457-2017 Merge Hemo software
Creator: Merge Healthcare, Inc.
Published: 2016-04-04
License: https://open.fda.gov/license/

Merge Healthcare Incorporated / initiated 2016-04-04 / Terminated / root cause: software

FDA source

Merge Healthcare, Inc. began a recall of Merge Hemo software. Product Usage: Merge Hemo is a hemodynamic monitoring system that records and displays physiological data on 2016-04-04. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1457-2017
Classification: Class II
Status: Terminated
Initiated: 2016-04-04
Posted: 2017-03-14
Terminated: 2019-08-05
Recalling firm: Merge Healthcare Incorporated
Product: Merge Hemo software. Product Usage: Merge Hemo is a hemodynamic monitoring system that records and displays physiological data.
Product code: DQK Computer, Diagnostic, Programmable
Reason for recall: 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.
Root cause tag: software
FDA root cause: Software design
Action: The recalling firm issued a letter dated March 28, 2016 via e-mail. If no email address was available, the letters were issued via certified mail. Non-responders were issued letters on July 11, 2016. The letter identified the affected product, problem and actions to be taken. For question send an email to [email protected].
Quantity in commerce: 361 sites potentially have the affected versions
Distribution: US Nationwide Distribution.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1457-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1457-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-22	2017-03-13

Product code DQK

K082421Class IIHeartsuite Hemodynamics 7.10Emageon, Inc. / cleared 2008-12-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)