Merge Eye Care Systems, consisting of Merge Eye Station… recallZ-1681-2017 · Merge Healthcare, Inc. · initiated Apr 4, 2016
Class II Terminated All recalls posted in March 2017
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Merge Healthcare, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The system will completely stop allowing the downloading or acquisition of new images due to incompatible software application versions.
FDA root cause category: Software Design Change
What the company is doing
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.
Recall details
- Recall number
- Z-1681-2017
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Apr 4, 2016
- Posted by the FDA
- Mar 13, 2017
- Recalling firm
- Merge Healthcare, Inc.
- Quantity
- 1,627 sites potentially have the affected software
- Product code
- NFJ
- FDA submissions
- K110006, K913929
- 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 description
Merge Eye Care Systems, consisting of Merge Eye Station, Merge Eye Care PACS, and Merge Eye Station Import Utility (ESIU).
Code information (models, lots, serial numbers)
All versions of Eye Care PACS, Eye Station, and ESIU.
Other devices under the same FDA submission
1 device cleared under K110006, K913929 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Merge Eye Station 11.6.1Merge Healthcare Solutions Inc. · System, Image Management, Ophthalmic1 recall1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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