Z-2347-2015Class II

Merge Hemo, 9.10, 9.20.0, 9.20.1,9.20.2, 9.30, 9.40.0, 9.40.1, 9.40.2 with Massimo PHASEIN End Tidal CO2...

Name: Z-2347-2015 Merge Hemo, 9.10, 9.20.0, 9.20.1,9.20.2, 9.30, 9.40.0, 9.40.1, 9.40.2 with Massimo PHASEIN End Tidal CO2...
Creator: Merge Healthcare, Inc.
Published: 2015-01-21
License: https://open.fda.gov/license/

Merge Healthcare Incorporated / initiated 2015-01-21 / Terminated / root cause: software

FDA source

Merge Healthcare, Inc. began a recall of Merge Hemo, 9.10, 9.20.0, 9.20.1,9.20.2, 9.30, 9.40.0, 9.40.1, 9.40.2 with Massimo PHASEIN End Tidal CO2 (EtCO2) module. Merge Hemo (formerly named HeartSuite... on 2015-01-21. FDA classified it as Class II and gives the reason as "A system freeze-up of the Merge Hemo system, that included the PHASEIN End Tidal CO2 unit, resulted in the user needing to move the patient to another cath lab". 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-2347-2015
Classification: Class II
Status: Terminated
Initiated: 2015-01-21
Posted: 2015-08-06
Terminated: 2015-12-09
Recalling firm: Merge Healthcare Incorporated
Product: Merge Hemo, 9.10, 9.20.0, 9.20.1,9.20.2, 9.30, 9.40.0, 9.40.1, 9.40.2 with Massimo PHASEIN End Tidal CO2 (EtCO2) module. 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: A system freeze-up of the Merge Hemo system, that included the PHASEIN End Tidal CO2 unit, resulted in the user needing to move the patient to another cath lab.
Root cause tag: software
FDA root cause: Software design
Action: Merge Healthcare sent an Important Product Information letter dated January 21, 2015, to all affected consignees. The letter described the Issue, Affected Product, Instructions, Product Updates, and Contact Information. For questions contact Merge Customer Service at (877) 741-5369 or [email protected] A second UPDATE letter was sent April 16, 2015. The letter included the Product Updates. For questions regarding this recall call 866-261-5761.
Quantity in commerce: 451
Distribution: Nationwide Distribution including IL, SC, WI, AL, CT, CA, LA, NM, TX, OK, GA, IA, OH, FL, CO, TN, NY, NC, MA, AR, MO, HI, ND, AK, UT, WV, WA, AZ, MI, PA, ME.
Product codes and lots: Merge Hemo with software versions 9.10, 9.20.0, 9.20.1, 9.20.2, 9.30, 9.40.0, 9.40.1, 9.40.2 are affected only if used with any Masimo PHASEIN EtCO2 module

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2347-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2347-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-12	2015-08-06

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)