Merge Eye Care Systems Software Recall Due to Image Acquisition Failure
Merge Healthcare is recalling Eye Care Systems software because incompatible versions prevent the downloading or acquisition of new images.
What this means for you
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. The hazard is a functional software failure that prevents image acquisition, which is a significant operational issue but does not involve a direct physical injury or death risk to patients.
Plain-English summary
Merge Healthcare, Inc. is recalling Merge Eye Care Systems, which includes the Merge Eye Station, Merge Eye Care PACS, and Merge Eye Station Import Utility (ESIU). The recall affects all versions of these software components.
The recall is being issued because the system will completely stop allowing the downloading or acquisition of new images due to incompatible software application versions. This functional failure prevents the software from performing its intended purpose of handling medical images.
Distribution was made to medical facilities nationwide, as well as to government facilities. The software was also distributed to Canada and other countries, but there was no military distribution. Approximately 1,627 sites potentially have the affected software. Users should contact Merge Healthcare for instructions on resolving the software incompatibility.
The recalled product
- Product
- Merge Eye Care Systems, consisting of Merge Eye Station, Merge Eye Care PACS, and Merge Eye Station Import Utility (ESIU).
- Manufacturer
- Merge Healthcare, Inc.
- Category
- Medical Device — Software
- Affected units
- 1,627
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)
- All versions of Eye Care PACS
- Eye Station
- and ESIU.
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 · software failure
See all →- ModerateFoundation Medicine Recalls Hamilton Microlab STAR Liquid Handler Software
FDA (Devices) · 2026-08-26
- SevereOlympus High Flow Insufflation Unit Recalled Due to Software Overpressure Risk
FDA (Devices) · 2026-02-25
- ModerateStryker Blueprint Mixed Reality Glenoid Box Lid system functionality issues
FDA (Devices) · 2025-04-16
- ModerateStryker Blueprint Mixed Reality Glenoid Pin Guide Impaired Function Recall
FDA (Devices) · 2025-04-16
- HighMerlin PCS 3650 Pacemaker Programmer Software Anomaly May Cause Loss of Pacing
FDA (Devices) · 2025-01-01