Z-2341-2016Class II

Merge HEMO software

Name: Z-2341-2016 Merge HEMO software
Creator: Merge Healthcare, Inc.
Published: 2012-07-02
License: https://open.fda.gov/license/

Merge Healthcare Incorporated / initiated 2012-07-02 / Terminated / root cause: software

FDA source

Merge Healthcare, Inc. began a recall of Merge HEMO software on 2012-07-02. FDA classified it as Class II and gives the reason as "The International Normalized Ratio (INR) value displayed in the study report does not match the value that is imported on the pre-procedure labs screen from HL7". 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-2341-2016
Classification: Class II
Status: Terminated
Initiated: 2012-07-02
Posted: 2016-08-04
Terminated: 2017-06-26
Recalling firm: Merge Healthcare Incorporated
Product: Merge HEMO software.
Product code: DQK Computer, Diagnostic, Programmable
Reason for recall: The International Normalized Ratio (INR) value displayed in the study report does not match the value that is imported on the pre-procedure labs screen from HL7
Root cause tag: software
FDA root cause: Software design
Action: The firm issued an "Important Product Information" bulletin to customers dated 7/2/2012 via e-mail letting them know there was an upgrade available. On 1/30/2016, the recalling firm initiated phone calls to their customers letting them know there was an upgrade available and if they declined it, they would like a written response.
Quantity in commerce: 37
Distribution: The medical facilities who currently have the affected versions are located nationwide. There was government distribution but no military or foreign distribution.
Product codes and lots: Software versions 8.10, 9.10, 9.20.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2341-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2341-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-10	2016-08-04

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)