Merge Cardio software recall for missing patient information on report pages
Merge Healthcare is recalling Merge Cardio software version 10.1 because patient information is missing from subsequent report pages.
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, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a software defect affecting data display, which aligns with the criteria for a moderate severity score involving minor labeling or data errors without reported harm.
Plain-English summary
Merge Healthcare, Inc. is recalling Merge Cardio software, version 10.1. This software is an integrated cardiovascular information system classified as a picture archiving and communications system.
The recall is due to a defect where patient information in the header is only found on the first page of the report and is not present on subsequent pages. This issue could affect the accuracy of patient records within the system.
The recall is distributed nationwide in the United States. Approximately 42 sites potentially have the affected version of the software. Users of the software should contact Merge Healthcare for further instructions on how to resolve the issue.
The recalled product
- Product
- Merge Cardio software. Product Usage: Merge Cardio is an integrated cardiovascular information system classified as a picture archiving and communications system.
- Manufacturer
- Merge Healthcare, Inc.
- Category
- Medical Device — Software
- Hazard
- Affected units
- 42
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 (1)
- Version 10.1
Distribution
Distributed nationwide across the United States.
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