Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1486-2017·Announced 2017-03-29

Merge Healthcare Recalls Cardio Software Due to STAT Study Display Issue

Merge Healthcare is recalling Merge Cardio software versions 9.0 through 10.1.2 because the study list fails to display STAT studies without a manual refresh.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard is a software display error that may delay the visibility of STAT studies, but the source text does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall involving a risk-of-harm product without reported adverse events.

Plain-English summary

Merge Healthcare, Inc. is recalling Merge Cardio software versions 9.0 through 10.1.2. The recall is due to a software defect where the cardio study list does not show STAT studies unless the user manually refreshes the screen.

The affected software was distributed nationwide to medical facilities and to military facilities. There was no foreign or government distribution outside of these channels. Approximately 217 sites potentially have the affected versions installed.

Healthcare facilities should contact Merge Healthcare for instructions on how to resolve the issue. The source text does not specify a corrective action, such as a software patch or replacement, but the recall is active for the listed versions.

The recalled product

Product: Merge Cardio software.
Manufacturer: Merge Healthcare, Inc.
Category: Medical Device — Software
Hazard: software-defect
delayed-information
Affected units: 217

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 (15)

Versions 9.0
9.0.1
9.0.2
9.0.3
9.0.4
9.0.5
9.0.6
9.0.7
9.0.8
9.0.9
10.0
10.0.1
10.1
10.1.1
and 10.1.2.

Distribution

Distributed nationwide across the United States.

Same manufacturer · Merge Healthcare, Inc.

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