Merge Cardio Software Recall Due to Missing Read-Only Notification
Merge Healthcare is recalling Merge Cardio software versions 9.0.9 and earlier because a defect allows two physicians to access the same study report without a read-only prompt.
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 is a software defect affecting data integrity and workflow (missing read-only prompt) rather than a direct physical safety risk like a device malfunction causing injury. No injuries or illnesses are reported.
Plain-English summary
Merge Healthcare, Inc. is recalling Merge Cardio software using EchoIMS, specifically versions 9.0.9 and earlier. The recall is due to a software defect that can allow two physicians to access the same study report in EchoIMS when launched from the Cardio Study List. In this scenario, the users do not receive the standard read-only notification prompt.
The affected software was distributed to medical facilities in California, Florida, Illinois, Maryland, Missouri, Ohio, Oklahoma, Texas, Vermont, and Wisconsin. Military distribution was also made. Approximately 17 sites potentially have the affected versions.
Healthcare facilities should contact Merge Healthcare for instructions on how to resolve the issue. No specific instructions for end-users are provided in the source text, but facilities should ensure they are using updated software versions to prevent concurrent access to study reports.
The recalled product
- Product
- Merge Cardio software using EchoIMS. The firm name on the label is Merge Healthcare, Hartland, WI.
- Manufacturer
- Merge Healthcare, Inc.
- Category
- Medical Device — Software
- Affected units
- 17
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 9.0.9 and earlier using EchoIMS.
Distribution
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