Merge Healthcare, Inc.: Medical Device Recall in 2015 - (Recall #: Z-2347-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: January 21, 2015

Date Posted: August 12, 2015

Recall Number: Z-2347-2015

Event ID: 71814

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.

Status: Terminated

Product Quantity: 451

Code Information:

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

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated