Merge Hemo software recalled due to study tab locking issue
Merge Healthcare is recalling Merge Hemo software versions 6.10 through 9.40.3 because the system may incorrectly lock study tabs, potentially preventing access to data.
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, and the hazard involves a software malfunction that may impede data access but does not explicitly report injuries, deaths, or direct physiological harm, fitting the criteria for a moderate severity issue.
Plain-English summary
Merge Healthcare, Inc. is recalling specific versions of Merge Hemo software, a hemodynamic monitoring system used to record and display physiological data. The affected software versions include 6.10, 6.10.1, 6.10.2, 6.10.3, 7.10, 7.20, 7.20.1, 8.10.0, 8.20, 9.10.0, 9.20, 9.20.2, 9.20.3, 9.30, 9.40, 9.40.1, 9.40.2, and 9.40.3.
The recall was initiated because, in some instances, the system will lock tabs within a study even when a second user does not have the study open on a different workstation. This issue may interfere with the ability of users to access or manage study data as intended.
The affected software was distributed nationwide in the United States, with 361 sites potentially having the affected versions. Users of Merge Hemo software should contact Merge Healthcare, Inc. for information regarding corrective actions or software updates.
The recalled product
- Product
- Merge Hemo software. Product Usage: Merge Hemo is a hemodynamic monitoring system that records and displays physiological data.
- Manufacturer
- Merge Healthcare, Inc.
- Category
- Medical Device — Software
- Affected units
- 361
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 (18)
- Versions 6.10
- 6.10.1
- 6.10.2
- 6.10.3
- 7.10
- 7.20
- 7.20.1
- 8.10.0
- 8.20
- 9.10.0
- 9.20
- 9.20.2
- 9.20.3
- 9.30
- 9.40
- 9.40.1
- 9.40.2
- and 9.40.3
Distribution
Distributed nationwide across the United States.
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