The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0665-2017·Announced 2016-12-07

Merge Healthcare Recalls Hemo Software Due to Potential Application Crashes

Merge Healthcare is recalling Merge Hemo software versions 9.10 through 9.40.2 because the application may crash during cardiac catheterization procedures.

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 medical device software defect that could compromise patient monitoring 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 in hospital cardiac catheterization laboratories to monitor, measure, and record physiologic data from patients undergoing cardiac catheterization procedures. The affected software versions are 9.10, 9.20.0, 9.20.2, 9.30.0, 9.40.0, 9.40.1, and 9.40.2, specifically when running on the Windows 7 Operating System.

The recall is being issued because the application may crash during the cath lab procedure. The source text does not report any specific injuries, illnesses, or deaths associated with this defect. The recall is classified as Class II by the FDA, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Approximately 192 sites nationwide potentially have the affected software. The source text does not provide specific instructions for consumers or healthcare providers on how to resolve the issue, such as software updates or replacements. Healthcare facilities using this software should contact the manufacturer or refer to the FDA recall notice for specific remediation steps.

The recalled product

Product
Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. The Monitoring System is for the monitoring of vital parameters including ECG, SpO2, invasive blood pressure, temperature…
Manufacturer
Merge Healthcare, Inc.
Category
Medical Device — Software
Hazard
Affected units
192

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 (7)

  • Versions 9.10
  • 9.20.0
  • 9.20.2
  • 9.30.0
  • 9.40.0
  • 9.40.1
  • and 9.40.2 with Windows 7 Operating System

Distribution

Distributed nationwide across the United States.

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