Z-1246-2017Class II

Merge Eye Station Import Utility (ESIU) when used with Merge Eye Station and Merge Eye Care PACS. The firm...

Name: Z-1246-2017 Merge Eye Station Import Utility (ESIU) when used with Merge Eye Station and Merge Eye Care PACS. The firm...
Creator: Merge Healthcare, Inc.
Published: 2016-03-28
License: https://open.fda.gov/license/

Merge Healthcare Incorporated / initiated 2016-03-28 / Terminated / root cause: design

FDA source

Merge Healthcare, Inc. began a recall of 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... on 2016-03-28. FDA classified it as Class II and gives the reason as "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)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1246-2017
Classification: Class II
Status: Terminated
Initiated: 2016-03-28
Posted: 2017-02-23
Terminated: 2020-04-17
Recalling firm: Merge Healthcare Incorporated
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.
Product code: NFJ System, Image Management, Ophthalmic
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)
Root cause tag: design
FDA root cause: Device Design
Action: The recalling firm issued a letter dated 3/28/2016 via e-mail. If no email address was available, the letters were issued via certified mail. A follow-up letter dated 7/11/2016 was also issued.
Quantity in commerce: 1,627 sites potentially have the affected versions
Distribution: Distribution was nationwide to medical facilities. There was also government and foreign distribution, including Canada.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1246-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1246-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-01	2017-02-23

Product code NFJ

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)