Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1246-2017·Announced 2017-03-01

Merge Eye Station Import Utility Recalled for Image Import Errors

Merge Healthcare is recalling the Eye Station Import Utility because images were not importing properly and were imported under "unknown" due to a validation issue.

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: This is an FDA Class II recall involving a software defect that causes data integrity issues (images imported as 'unknown') but does not involve a direct physical hazard or reported injuries, fitting the criteria for a moderate severity software recall.

Plain-English summary

Merge Healthcare, Inc. is recalling the Merge Eye Station Import Utility (ESIU) when used with Merge Eye Station and Merge Eye Care PACS. The recall is due to a software issue where eye station images were not importing properly and were imported under "unknown" when validating patients using only a Medical Record Number (MRN).

The affected software versions include Merge ESIU versions 1.0, 1.1.1, 1.1.2, and 1.1.3; all versions of Merge Eye Station; and Merge Eye Care PACS versions 4.1, 4.2, 4.3, 5.0, and 5.1. The product was distributed nationwide to medical facilities, as well as to government and foreign locations including Canada. Approximately 1,627 sites potentially have the affected versions.

Medical facilities should contact Merge Healthcare for further instructions on how to resolve the issue. The U.S. Food and Drug Administration has classified this as a Class II recall.

The recalled product

Product: Merge Eye Station Import Utility (ESIU) when used with Merge Eye Station and Merge Eye Care PACS. The firm name on the labeling is Merge Healthcare, Hartland, WI.
Manufacturer: Merge Healthcare, Inc.
Category: Medical Device — Software
Hazard: software-defect
data-integrity
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 (10)

Merge ESIU: Versions 1.0
1.1.1
1.1.2
and 1.1.3
Merge Eye Station: All versions
Merge Eye Care PACS: Versions 4.1
4.2
4.3
5.0
and 5.1

Distribution

Distributed nationwide across the United States.

Same manufacturer · Merge Healthcare, Inc.

See all →

High
Merge Healthcare Recalls PACS Workstations Due to Inaccurate Measurements
FDA (Devices) · 2026-09-02
High
Merge PACS Medical Imaging Workstation Recalled Due to Patient Data Display Error
FDA (Devices) · 2026-08-12
Severe
Merge OrthoPACS Imaging Workstation Recall for Patient Data Display Issue
FDA (Devices) · 2026-08-12
Moderate
Hemodynamic recording systems recalled over pressure sensor error during blood pressure measurement
FDA (Devices) · 2025-09-10
High
Cardiovascular Information System Measurement Inconsistency in Merge Cardio
FDA (Devices) · 2025-03-26

Same hazard · software defect