Merge Cardio software recall due to patient data display error
Merge Healthcare is recalling Merge Cardio software versions with IPID because the system may display images from different patients as if they belong to the same individual.
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 misdiagnosis or treatment errors, but no injuries or illnesses have been reported, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Merge Healthcare, Inc. is recalling Merge Cardio software versions 8.30 through 10.1 that include the Issuer of Patient ID (IPID) feature. The recall is due to a software defect where the system may display study lists and images from different patients as though they belong to the same patient if those patients share the same first name, last name, and medical record number.
The affected software was distributed to medical facilities in Georgia, Illinois, Maryland, Michigan, Missouri, Ohio, Tennessee, and Vermont. There was no foreign, government, or military distribution. Sixteen sites were originally identified as potentially having the affected versions.
Healthcare facilities using the affected software should contact Merge Healthcare for instructions on how to resolve the issue. Patients who may have been affected by the data display error should consult their healthcare providers to verify the accuracy of their medical records and imaging studies.
The recalled product
- Product
- Merge Cardio software with Issuer of Patient ID (IPID). The firm name on the label is Merge Healthcare, Hartland, WI.
- Manufacturer
- Merge Healthcare, Inc.
- Category
- Medical Device — Software
- Affected units
- 16
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 (13)
- Versions 8.30
- 9.0
- 9.0.1
- 9.0.2
- 9.0.3
- 9.0.4
- 9.0.5
- 9.0.6
- 9.0.7
- 9.0.8
- 10.0
- 10.0.1
- and 10.1 with Issuer of Patient ID (IPID)
Distribution
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
Same hazard · data integrity
See all →- ModeratePhilips Ingenia Blue Seal MRI Systems Recalled for DTI Export Errors
FDA (Devices) · 2026-10-07
- SevereVolcano Corp Recalls Philips IntraSight Plus Systems Due to Data Error
FDA (Devices) · 2026-10-07
- ModeratePhilips Ingenia Ambition MRI Systems Recalled for Incorrect DTI Data Exports
FDA (Devices) · 2026-10-07
- ModeratePhilips MR 7700 Software Upgrade Recalled for Incorrect DTI Data
FDA (Devices) · 2026-10-07
- ModeratePhilips SmartPath to MR 7700 Recalled for Incorrect DTI Export Data
FDA (Devices) · 2026-10-07
Similar recalls
- HighMerge Cardio software recall due to incorrect patient data saving
FDA (Devices) · 2016-09-07
- HighMerge Healthcare Recalls Merge Cardio Software Due to Data Integrity Issues
FDA (Devices) · 2017-03-29
- ModerateMerge Cardio software recalled for incorrect measurement units in reports
FDA (Devices) · 2017-03-15
- HighMerge Cardio software recalled for incorrect fetal measurement data retrieval
FDA (Devices) · 2017-05-31
- ModerateMerge Cardio software recall for missing patient information on report pages
FDA (Devices) · 2016-09-28
- HighMerge Cardio software recalled for potential image loading errors
FDA (Devices) · 2017-01-25