Agency classClass IIOur severity:High FDA (Devices)·Z-2347-2015·Announced 2015-08-12

Merge Hemo System Recalled for Freeze-Up During Cardiac Procedures

Merge Healthcare is recalling 451 Merge Hemo systems used with Masimo PHASEIN modules due to system freeze-ups that required moving patients to other cath labs.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (medical device) where a system failure required moving a patient, but no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Merge Healthcare, Inc. is recalling 451 units of the Merge Hemo system (formerly HeartSuite Hemodynamics) in software versions 9.10 through 9.40.2. The recall applies only to systems used with a Masimo PHASEIN End Tidal CO2 (EtCO2) module. These devices are used to monitor, measure, and record physiologic data from patients undergoing cardiac catheterization procedures.

The recall was initiated because a system freeze-up occurred when the Merge Hemo system was used with the PHASEIN End Tidal CO2 unit. This malfunction resulted in the user needing to move the patient to another cath lab. The affected units were distributed nationwide, including in Illinois, South Carolina, Wisconsin, Alabama, Connecticut, California, Louisiana, New Mexico, Texas, Oklahoma, Georgia, Iowa, Ohio, Florida, Colorado, Tennessee, New York, North Carolina, Massachusetts, Arkansas, Missouri, Hawaii, North Dakota, Alaska, Utah, West Virginia, Washington, Arizona, Michigan, and Pennsylvania.

Healthcare facilities should identify affected units and contact Merge Healthcare for instructions on corrective actions. Consumers are not directly affected as this is a professional medical device used in clinical settings.

The recalled product

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…
Manufacturer: Merge Healthcare, Inc.
Category: Medical Device — Cardiac Monitoring
Hazard: system-freeze
patient-transfer
Affected units: 451

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (8)

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

Distributed nationwide across the United States.

The notice also names 31 states specifically:

Same manufacturer · Merge Healthcare, Inc.

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