Z-0554-2016Class II

Merge Hemo with software versions 10.0 LA. Merge Hemo (formerly named HeartSuite Hemodynamics) monitors...

Name: Z-0554-2016 Merge Hemo with software versions 10.0 LA. Merge Hemo (formerly named HeartSuite Hemodynamics) monitors...
Creator: Merge Healthcare, Inc.
Published: 2015-10-26
License: https://open.fda.gov/license/

Merge Healthcare Incorporated / initiated 2015-10-26 / Terminated / root cause: manufacturing process

FDA source

Merge Healthcare, Inc. began a recall of Merge Hemo with software versions 10.0 LA. Merge Hemo (formerly named HeartSuite Hemodynamics) monitors, measures, and records physiologic data from a human... on 2015-10-26. FDA classified it as Class II and gives the reason as "The firm, Merge Healthcare, sent out Merge HEMO V10.0 & Merge CARDIO V10.1 software to 3 customers before the product was completely validated in house". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0554-2016
Classification: Class II
Status: Terminated
Initiated: 2015-10-26
Posted: 2015-12-28
Terminated: 2016-07-22
Recalling firm: Merge Healthcare Incorporated
Product: Merge Hemo with software versions 10.0 LA. Merge Hemo (formerly named HeartSuite Hemodynamics) monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure.
Product code: DQK Computer, Diagnostic, Programmable
Reason for recall: The firm, Merge Healthcare, sent out Merge HEMO V10.0 & Merge CARDIO V10.1 software to 3 customers before the product was completely validated in house.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Consignees were either contacted via phone 9/2015 or in person 7/31/2015. The customer communications involved the need to upgrade the consignees software. Merge Healthcare did not script the conversations because they opted to hold one-on-one management level discussions to carefully explain the importance of moving to the Generally Available (GA) release.
Quantity in commerce: 2
Distribution: Distributed in the states of IL, NC, and VT.
Product codes and lots: Merge Hemo with software versions 10.0 LA

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0554-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0554-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-06	2015-12-28
Z-0555-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-06	2015-12-28

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)