Merge Eye Station Import Utility Recalled for System Lockup Risk
Merge Healthcare is recalling the Eye Station Import Utility software because system lockups may cause patient injury or delay diagnosis.
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 involves a risk of patient injury or delayed treatment, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Merge Healthcare, Inc. is recalling the Merge Eye Station Import Utility (ESIU) software, versions 1.1.2 and 1.1.3. The recall is due to a defect where the system may lock up, which could result in potential patient injury or a delay in diagnosis or treatment.
The affected software was distributed nationwide in the United States to medical facilities, as well as to Canada. The source indicates that 78 sites potentially have the affected accessory. Government distribution was made, but there was no military distribution.
Medical facilities should contact Merge Healthcare for further instructions on how to address the software defect.
The recalled product
- Product
- Merge Eye Station Import Utility (ESIU). The firm name on the labeling is Merge Healthcare.
- Manufacturer
- Merge Healthcare, Inc.
- Category
- Medical Device — Software
- Affected units
- 78
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)
- Versions 1.1.2 and 1.1.3
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 · system failure
See all →- HighDxI 9000 Access Immunoassay Analyzer calibration system error recall
FDA (Devices) · 2025-07-02
- HighXhibit Telemetry Receiver may shut down, causing temporary loss of patient monitoring
FDA (Devices) · 2025-01-15
- HighBD Pyxis MedStation 4000 Medication Cabinet Fire Risk Recall
FDA (Devices) · 2024-06-05
- HighPhilips Allura Xper X-ray systems disk bay component may malfunction
FDA (Devices) · 2024-02-28
- HighMedfusion Syringe Pumps Recalled for Force Sensor Calibration Drift
FDA (Devices) · 2023-10-18