Z-0665-2017Class II

Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human patient...

Name: Z-0665-2017 Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human patient...
Creator: Merge Healthcare, Inc.
Published: 2014-04-30
License: https://open.fda.gov/license/

Merge Healthcare Incorporated / initiated 2014-04-30 / Terminated / root cause: software

FDA source

Merge Healthcare, Inc. began a recall of Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. The... on 2014-04-30. FDA classified it as Class II and gives the reason as "The application may crash during the cath lab procedure". 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-0665-2017
Classification: Class II
Status: Terminated
Initiated: 2014-04-30
Posted: 2016-11-28
Terminated: 2019-12-23
Recalling firm: Merge Healthcare Incorporated
Product: Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. The Monitoring System is for the monitoring of vital parameters including ECG, SpO2, invasive blood pressure, temperature, NIBP and CO2, and for the evaluation of resting ECG, arrhythmias, ST-segments and cardiac output. Some systems are built and designed to measure End Tidal CO2. The system is intended for use in hospital cardiac catheterization laboratories
Product code: DQK Computer, Diagnostic, Programmable
Reason for recall: The application may crash during the cath lab procedure.
Root cause tag: software
FDA root cause: Software design
Action: Merge sent an Important Alert letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers with questions were instructed to contact Merge Support at 866-261-5761 or [email protected]. For questions regarding this recall call 877-741-5369.
Quantity in commerce: 192 sites potentially have the affected software
Distribution: Nationwide Distribution
Product codes and lots: Versions 9.10, 9.20.0, 9.20.2, 9.30.0, 9.40.0, 9.40.1, and 9.40.2 with Windows 7 Operating System

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0665-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0665-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-07	2016-11-28

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)