Merge Hemo software recall due to potential connection issues
Merge Healthcare is recalling Merge Hemo software versions 6.10 through 9.40.3 because the Hemo Monitor may fail to communicate with the Client PC during power-up.
What this means for you
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 is classified as FDA Class II, and the hazard involves a risk-of-harm product (medical device software) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Merge Healthcare, Inc. is recalling specific versions of the Merge Hemo software. This software is used to monitor, measure, and record physiologic data from human patients undergoing cardiac catheterization procedures. The affected 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 is due to a potential connection issue where the Hemo Monitor does not communicate with the Client PC when powering up the Merge Hemo Record Station. This failure to communicate could impact the monitoring and recording of patient data during procedures.
The product was distributed nationwide, and 242 sites potentially have the affected versions. The U.S. Food and Drug Administration has classified this as a Class II recall. Users of the affected software should contact Merge Healthcare, Inc. for further instructions on how to address the issue.
The recalled product
- Product
- Merge Hemo software. Merge Hemo 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
- 242
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.
Related recalls
Same manufacturer · Merge Healthcare, Inc.
See all →- HighMerge Healthcare Recalls PACS Workstations Due to Inaccurate Measurements
FDA (Devices) · 2026-09-02
- SevereMerge OrthoPACS Imaging Workstation Recall for Patient Data Display Issue
FDA (Devices) · 2026-08-12
- HighMerge PACS Medical Imaging Workstation Recalled Due to Patient Data Display Error
FDA (Devices) · 2026-08-12
- ModerateHemodynamic recording systems recalled over pressure sensor error during blood pressure measurement
FDA (Devices) · 2025-09-10
- HighVERICIS Merge Cardio Medical Device Software Measurement Data Consistency Issue
FDA (Devices) · 2025-03-26
Same hazard · connection failure
See all →- HighRapid Refill Continuous Injection System Recalled for Syringe Loosening Risk
FDA (Devices) · 2026-07-22
- HighBD Connecta stopcock Port C may over thread rather than tightening
FDA (Devices) · 2026-06-24
- SevereHalyard CATH LAB Kit Due to Syringe Adapter Disconnection Risk
FDA (Devices) · 2026-05-13
- SevereHalyard SAMMC Angiography Kit syringe rotating adapter unwinding recall
FDA (Devices) · 2026-05-13
- SevereHalyard Cardiac Catheterization Tray Kits Recalled for Connection Risk
FDA (Devices) · 2026-05-13