Z-1498-2017Class II

Merge Eye Station Import Utility (ESIU). The firm name on the labeling is Merge Healthcare

Name: Z-1498-2017 Merge Eye Station Import Utility (ESIU). The firm name on the labeling is Merge Healthcare
Creator: Merge Healthcare, Inc.
Published: 2016-04-04
License: https://open.fda.gov/license/

Merge Healthcare Incorporated / initiated 2016-04-04 / Terminated / root cause: software

FDA source

Merge Healthcare, Inc. began a recall of Merge Eye Station Import Utility (ESIU). The firm name on the labeling is Merge Healthcare on 2016-04-04. FDA classified it as Class II and gives the reason as "System locks up which may result in potential patient injury or delay in diagnosis or treatment". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1498-2017
Classification: Class II
Status: Terminated
Initiated: 2016-04-04
Posted: 2017-03-20
Terminated: 2020-06-15
Recalling firm: Merge Healthcare Incorporated
Product: Merge Eye Station Import Utility (ESIU). The firm name on the labeling is Merge Healthcare.
Product code: OUG Medical Device Data System
Reason for recall: System locks up which may result in potential patient injury or delay in diagnosis or treatment.
Root cause tag: software
FDA root cause: Software design
Action: Merge Healthcare, Inc. sent an Urgent: Medical Device Recall letter dated March 28, 2016, via email on April 4, 2016. If no email address was available, the letters were issued via certified mail. Nonresponders were issued letters dated July 11, 2016, via email. The letter notifies the customer of the issue and informs them of the workaround and that a fix was not yet available, although they were working on one. The notification instructs the customer to pass the information onto all other users, as well as any downstream customers if it was further distributed. The notification also informs the customer their response is required using the enclosed form and the return addressed envelope. The response form asks, in part, if they understand the workaround. The response was required no later than April 18, 2016. Nonresponders were issued a second letter dated July 11, 2016, asking for a response by August 2, 2016. The letter and response form contained the same information as the first letter. If the second letter results in additional unresponsive customers, a call campaign will be managed by Customer Support and documented via SalesForce. Three call attempts will made before closing the case. The recalling firm reported emails will be tracked for delivery confirmation and the letters will be tracked for delivery by USPS certified services. For further questions, please call (877) 741-5369.
Quantity in commerce: 78 sites potentially have the affected accessory
Distribution: Distribution was made USA (nationwide) to medical facilities. Government distribution was made. Foreign distribution was made to Canada. There was no military distribution.
Product codes and lots: Versions 1.1.2 and 1.1.3

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1498-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1498-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-29	2017-03-20

Product code OUG

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)