The Recall Desk
HighFDA (Devices)·Z-1778-2017·Announced 2017-04-19

Merge Hemo software recall for incorrect FFR results display

Merge Healthcare is recalling Merge Hemo software versions 9.10.0 through 9.40.0 because they may display incorrect Fractional Flow Reserve values during cardiac catheterization.

What this means for you

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 medical device software defect that could lead to incorrect clinical data (FFR values) during a procedure, representing a risk of harm where injury has not yet been reported, consistent with the 'High' severity criteria.

Plain-English summary

Merge Healthcare, Inc. is recalling specific versions of the Merge Hemo software. This software is used to monitor, measure, and record physiologic data from patients undergoing cardiac catheterization procedures. The affected versions are 9.10.0, 9.20.0, 9.20.1, 9.20.2, 9.30.3, and 9.40.0.

The recall was initiated because the software may display an incorrect value to the user when viewing Fractional Flow Reserve (FFR) results during recording. This potential error could affect the accuracy of the data recorded for the patient.

The affected software was distributed nationwide to 24 sites in Arizona, California, Colorado, Florida, Georgia, Kansas, Louisiana, Michigan, Missouri, Ohio, Oklahoma, Tennessee, Texas, Virginia, Washington, Wisconsin, and West Virginia. Healthcare facilities using these specific software versions should contact Merge Healthcare for further instructions.

The recalled product

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
Manufacturer
Merge Healthcare, Inc.
Category
Medical Device — Software
Hazard
Affected units
24

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 (6)

  • Versions 9.10.0
  • 9.20.0
  • 9.20.1
  • 9.20.2
  • 9.30.3
  • and 9.40.0.

Distribution

Distributed nationwide across the United States.

The notice also names 17 states specifically:

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