Merge HEMO software recall for inaccurate INR display
Merge Healthcare is recalling 37 units of Merge HEMO software because the displayed International Normalized Ratio (INR) value does not match the imported value.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device software defect that could lead to incorrect clinical decision-making (INR mismatch), which is a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Merge Healthcare, Inc. is recalling 37 units of Merge HEMO software, specifically versions 8.10, 9.10, and 9.20. The recall is due to a software defect where the International Normalized Ratio (INR) value displayed in the study report does not match the value imported on the pre-procedure labs screen from HL7.
The affected software is located in medical facilities nationwide. The distribution included government facilities, but there was no military or foreign distribution. The source text does not report any specific illnesses or injuries associated with this defect.
Healthcare facilities should contact Merge Healthcare, Inc. for further instructions regarding the software update or replacement.
The recalled product
- Product
- Merge HEMO software.
- Manufacturer
- Merge Healthcare, Inc.
- Category
- Medical Device — Software
- Affected units
- 37
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 (3)
- Software versions 8.10
- 9.10
- 9.20.
Distribution
Distributed nationwide across the United States.
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