Z-1778-2017Class II

Merge Hemo software. The firm name on the labeling is Merge Healthcare, Hartland, WI. Merge Hemo monitors...

Name: Z-1778-2017 Merge Hemo software. The firm name on the labeling is Merge Healthcare, Hartland, WI. Merge Hemo monitors...
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. The firm name on the labeling is Merge Healthcare, Hartland, WI. Merge Hemo monitors, measures, and records physiologic data from a human... on 2016-04-04. FDA classified it as Class II and gives the reason as "Use of the software may show an incorrect value to the user when viewing the Fractional Flow Reserve (FFR) results during recording". 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-1778-2017
Classification: Class II
Status: Terminated
Initiated: 2016-04-04
Posted: 2017-04-11
Terminated: 2019-02-21
Recalling firm: Merge Healthcare Incorporated
Product: Merge Hemo software. The firm name on the labeling is Merge Healthcare, Hartland, WI. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure
Product code: DQK Computer, Diagnostic, Programmable
Reason for recall: Use of the software may show an incorrect value to the user when viewing the Fractional Flow Reserve (FFR) results during recording.
Root cause tag: software
FDA root cause: Software design
Action: MERGE sent an Urgent Medical Device Recall letter dated April 4, 2016 to all affected customers via e-mail the week of April 4, 2016. If no email address was available, the letters were issued via certified mail. A second letter dated July 11, 2016 was issued to non-responders. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to ensure that all users of the affected product be provided with the notice. Customers were also asked to reply using the enclosed form and the return addressed envelope. Customers with questions were instructed to send an email to [email protected]. For questions regarding this recall call 877-741-5369.
Quantity in commerce: 24 sites potentially have the affected versions
Distribution: Nationwide Distribution including AZ, CA, CO, FL, GA, KS, LA, MI, MO, OH, OK, TN, TX, VA, WA, WI, and WV.
Product codes and lots: Versions 9.10.0, 9.20.0, 9.20.1, 9.20.2, 9.30.3, and 9.40.0.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1778-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1778-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-19	2017-04-11

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)