Z-1681-2017Class II

Merge Eye Care Systems, consisting of Merge Eye Station, Merge Eye Care PACS, and Merge Eye Station Import...

Name: Z-1681-2017 Merge Eye Care Systems, consisting of Merge Eye Station, Merge Eye Care PACS, and Merge Eye Station Import...
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 Care Systems, consisting of Merge Eye Station, Merge Eye Care PACS, and Merge Eye Station Import Utility (ESIU) on 2016-04-04. FDA classified it as Class II and gives the reason as "The system will completely stop allowing the downloading or acquisition of new images due to incompatible software application versions". 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-1681-2017
Classification: Class II
Status: Terminated
Initiated: 2016-04-04
Posted: 2017-03-13
Terminated: 2020-06-22
Recalling firm: Merge Healthcare Incorporated
Product: Merge Eye Care Systems, consisting of Merge Eye Station, Merge Eye Care PACS, and Merge Eye Station Import Utility (ESIU).
Product code: NFJ System, Image Management, Ophthalmic
Reason for recall: The system will completely stop allowing the downloading or acquisition of new images due to incompatible software application versions.
Root cause tag: software
FDA root cause: Software Design Change
Action: The recalling firm issued a letter dated 3/28/2016 via e-mail the week of 4/4/2016. If no email address was available, the letters were issued via certified mail.
Quantity in commerce: 1,627 sites potentially have the affected software
Distribution: Distribution was made to medical facilities nationwide. Government distribution was made. Foreign distribution was made to Canada, as well as other countries. There was no military distribution.
Product codes and lots: All versions of Eye Care PACS, Eye Station, and ESIU.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1681-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1681-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-05	2017-03-24

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)