Merge OrthoPACS Software Recalled for Annotation Display Error
Merge Healthcare is recalling Merge OrthoPACS software versions 6.6, 6.6.1, and 6.6.2 because prior studies may fail to display annotations.
What this means for you
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, which typically corresponds to a Moderate severity score (2) when no specific hospitalizations or serious injuries are reported in the source text, fitting the criteria for minor functional defects or low-risk issues.
Plain-English summary
Merge Healthcare, Inc. is recalling Merge OrthoPACS software versions 6.6, 6.6.1, and 6.6.2. The recall is due to a software defect where annotations may not display correctly when a prior study is loaded. Specifically, while a migrated study with annotations will display them, a subsequent prior study that should have annotations will not display those annotations.
The affected software was distributed nationwide to medical facilities. There was no foreign, government, or military distribution. Approximately 98 sites potentially have the affected versions installed.
This is a Class II recall, meaning the use of, or exposure to, the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. Users should contact Merge Healthcare for further instructions on resolving the issue.
The recalled product
- Product
- Merge OrthoPACS software.
- Manufacturer
- Merge Healthcare, Inc.
- Category
- Medical Device — Software
- Hazard
- Affected units
- 98
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 6.6
- 6.6.1
- and 6.6.2
Distribution
Distributed nationwide across the United States.
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