Merge Healthcare Recalls Unvalidated Cardio and HEMO Software Versions
Merge Healthcare is recalling Merge HEMO V10.0 and Merge CARDIO V10.1 software distributed to three customers before complete in-house validation.
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 the lack of complete in-house validation rather than a confirmed defect causing harm.
Plain-English summary
Merge Healthcare, Inc. is recalling Merge HEMO V10.0 and Merge CARDIO V10.1 software. The recall was initiated because the software was distributed to three customers before the product was completely validated in-house.
The affected software is intended to allow users to review diagnostic and non-diagnostic quality images. The recall covers one unit of the product, which was distributed in the states of Illinois, North Carolina, and Vermont.
No specific instructions for consumers are provided in the source text, but the recall is limited to the three customers who received the software prior to full validation.
The recalled product
- Product
- Merge Cardio with software version 10.1 LA.
- Manufacturer
- Merge Healthcare, Inc.
- Category
- Medical Device — Software
- Hazard
- Affected units
- 1
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.
See all 2 products in this recall →Related recalls
Same manufacturer · Merge Healthcare, Inc.
See all →- HighMerge Healthcare Recalls PACS Workstations Due to Inaccurate Measurements
FDA (Devices) · 2026-09-02
- HighMerge PACS Medical Imaging Workstation Recalled Due to Patient Data Display Error
FDA (Devices) · 2026-08-12
- SevereMerge OrthoPACS Imaging Workstation Recall for Patient Data Display Issue
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
Similar recalls
- HighMerge Healthcare Recalls Merge Cardio Software Due to Data Integrity Issues
FDA (Devices) · 2017-03-29
- HighMerge Cardio software recalled for potential image loading errors
FDA (Devices) · 2017-01-25
- ModerateMerge Cardio software recall for missing patient information on report pages
FDA (Devices) · 2016-09-28
- ModerateMerge Healthcare Recalls Cardio Software Due to STAT Study Display Issue
FDA (Devices) · 2017-03-29
- HighMerge Hemo software recall due to potential connection issues
FDA (Devices) · 2017-02-01
- HighMerge Cardio software recall due to incorrect patient data saving
FDA (Devices) · 2016-09-07