FDA Medical Device Recalls (openFDA)
Merge Healthcare, Inc.: Merge Eye Care Systems, consisting of Merge Eye Station, Merge Eye Care PACS, and Merge Eye Station Import Utility (ESIU).
- Recall number
- Z-1681-2017
- Recalling firm
- Merge Healthcare, Inc.
- Product
- Merge Eye Care Systems, consisting of Merge Eye Station, Merge Eye Care PACS, and Merge Eye Station Import Utility (ESIU).
- Status
- Terminated
- Initiated
- 2016-04-04
- Posted
- 2017-03-13
- Terminated
- 2020-06-22
- Reason
- The system will completely stop allowing the downloading or acquisition of new images due to incompatible software application versions.
- 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
- 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.
- Lot, serial or model codes
- All versions of Eye Care PACS, Eye Station, and ESIU.
- 510(k) numbers
- ["K110006","K913929"]
- PMA numbers
- not on file
- Product code
- NFJ
- Firm FEI
- 1000116130
- Firm city
- Hartland
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28