Merge Hemo Software Recalled Due to Incomplete Validation
Merge Healthcare is recalling Merge Hemo software version 10.0 LA because it was distributed to three customers before being fully validated in-house.
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, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is theoretical, stemming from incomplete validation rather than a confirmed defect causing harm, which aligns with the criteria for a moderate severity score.
Plain-English summary
Merge Healthcare, Inc. is recalling Merge Hemo software version 10.0 LA (formerly HeartSuite Hemodynamics). This software is used to monitor, measure, and record physiologic data from human patients undergoing cardiac catheterization procedures.
The recall was initiated because the firm distributed the software to three customers before the product was completely validated in-house. The affected units were distributed in the states of Illinois, North Carolina, and Vermont.
Consumers and healthcare facilities should contact Merge Healthcare for further instructions regarding the recall and replacement of the software.
The recalled product
- Product
- Merge Hemo with software versions 10.0 LA. Merge Hemo (formerly named HeartSuite Hemodynamics) monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure.
- Manufacturer
- Merge Healthcare, Inc.
- Category
- Medical Device — Software
- Hazard
- Affected units
- 2
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)
- Merge Hemo with software versions 10.0 LA
Distribution
Part of a larger recall action
This product is one of 2 recalled by Merge Healthcare, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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