Merge Cardio software recalled for incorrect measurement units in reports
Merge Healthcare is recalling Merge Cardio software versions 9.0 and 10.0 because measurements from images or US carts do not transfer to reports in the correct unit of measure.
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 involves incorrect data units in a medical software report, which is a significant functional defect but does not involve a high-risk pathogen, structural vehicle defect, or reported hospitalizations, fitting the Moderate criteria for a functional software error.
Plain-English summary
Merge Healthcare, Inc. is recalling Merge Cardio software versions 9.0 through 9.0.9 and 10.0. The recall is due to a defect where measurements taken from images on the Cardio workstation or from the US cart are not transferred to the report in the correct unit of measure.
The affected software was distributed to medical facilities nationwide. There was no foreign, military, or government distribution. Approximately 110 sites potentially have the affected versions.
The source text does not provide specific instructions for consumers or medical facilities on how to resolve the issue, nor does it report any illnesses or injuries associated with this defect.
The recalled product
- Product
- Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI.
- Manufacturer
- Merge Healthcare, Inc.
- Category
- Medical Device — Software
- Affected units
- 110
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 (11)
- 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
- and 10.0.
Distribution
Distributed nationwide across the United States.
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