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.

Eye Station images were not importing properly and were imported under "unknown" due to an issue when validating patients using only an Medical Record Number (MRN)

Recall #: Z-1246-2017
Affected scope: 1,627 sites potentially have the affected versions
Initiated: March 28, 2016

Compiled from official public sources by the publisher. · Updated September 2026

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Merge Healthcare, Inc. recalled Merge Eye Station Import Utility (ESIU) when used with Merge Eye Station and Merge Eye Ca… - a moderate-severity action.

Merge Eye Station Import Utility (ESIU) when used with Merge Eye Station and Merge Eye Ca… was recalled by Merge Healthcare, Inc. in March 1, 2017. Reason: Eye Station images were not importing properly and were imported under "unknown" due to an issue when validat…. Check the official notice for the remedy. Verify recall #Z-1246-2017 with the FDA Devices before acting.

The recall

Merge Healthcare, Inc. issued this moderate-severity FDA Devices recall-Eye Station images were not importing properly and were imported under "unknown" due to an issue when validat….

Moderate
severity level: Class II
classification: March 1, 2017
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-1246-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

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.

Reason for recall

Eye Station images were not importing properly and were imported under "unknown" due to an issue when validating patients using only an Medical Record Number (MRN)

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Terminated
Recall number	Z-1246-2017
Date reported	March 1, 2017
Date initiated	March 28, 2016
Recalling firm	Merge Healthcare, Inc.
Firm location	Hartland, WI
Affected scope	1,627 sites potentially have the affected versions
Distribution	Distribution was nationwide to medical facilities. There was also government and foreign distribution, including Canada.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-1246-2017) and product description against the item you own. Search the archive
Confirm the current status with FDA Devices before acting, recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

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.. Recalled by Merge Healthcare, Inc.. Units affected: 1,627 sites potentially have the affected versions.

Why was this product recalled? ▼

Eye Station images were not importing properly and were imported under "unknown" due to an issue when validating patients using only an Medical Record Number (MRN)

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on March 1, 2017. Severity: Moderate. Recall number: Z-1246-2017.

Where was the recalled product distributed? ▼

Distribution: Distribution was nationwide to medical facilities. There was also government and foreign distribution, including Canada..

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

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Similar severity · nearest report date

Same archive severity grade (Moderate), closest by report date among other firms and states.

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This recall: FDA Devices, reported March 1, 2017. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026