Merge Healthcare Recalls iConnect Access Software Due to Display Error
Merge Healthcare is recalling iConnect Access software versions 3.0.1, 3.1, and 3.2 because the software displayed incorrect prior reports when viewing multiple studies.
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, but the source text does not report any hospitalizations, injuries, or illnesses. The defect is a software display error, which fits the criteria for a moderate severity recall involving low-risk issues or voluntary precautionary measures without reported harm.
Plain-English summary
Merge Healthcare, Inc. is recalling iConnect Access software versions 3.0.1, 3.1, and 3.2. The recall was initiated because the software displayed incorrect prior reports in the viewport area when more than one prior study was viewed.
The affected software was distributed to medical facilities nationwide and also to foreign locations. Approximately 60 sites potentially have the affected versions installed.
The source text does not specify specific consumer actions or report any injuries or illnesses associated with this software defect.
The recalled product
- Product
- iConnect Access software. The firm name on the label is Merge Healthcare, Hartland, WI.
- Manufacturer
- Merge Healthcare, Inc.
- Category
- Medical Device — Software
- Affected units
- 60
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 (3)
- Versions 3.0.1
- 3.1
- and 3.2
Distribution
Distributed nationwide across the United States.
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