Merge Cardio software recall for data loss during inactivity
Merge Healthcare is recalling Merge Cardio software versions 10.1 and 10.1.1 because the reporting feature times out after one hour of inactivity, causing data loss.
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. The hazard involves data loss due to a software timeout, which is a functional defect rather than a direct physical injury risk, fitting the criteria for moderate severity.
Plain-English summary
Merge Healthcare, Inc. is recalling Merge Cardio software versions 10.1 and 10.1.1. The software is used to acquire, store, print, transfer, and archive clinical information, including images, hemodynamic studies, and reports.
The recall is due to a defect where the reporting feature times out if the user is inactive for more than an hour. This timeout sends the user back to the study list, resulting in the loss of all reporting data that was being entered.
The recall is classified as Class II by the FDA. The source text indicates that 116 sites potentially have the affected versions, with nationwide distribution. No specific instructions for consumers are provided in the source text.
The recalled product
- Product
- Merge Cardio software. Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information from Camtronics and other vendors systems including images, hemodynamic studies and reports, measurements (via import from DICOM Structured
- Manufacturer
- Merge Healthcare, Inc.
- Category
- Medical Device — Software
- Hazard
- Affected units
- 116
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)
- Versions V10.1 and 10.1.1
Distribution
Distributed nationwide across the United States.
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