Merge Eye Care Systems, consisting of Merge Eye Station, Merge Eye Care PACS, and Merge Eye Station Import Utility (ESIU
FDA device recall Z-1681-2017 · posted 2017-03-13 · Terminated
Recall details
- Recalling firm
- Merge Healthcare, Inc.
- Reason for recall
- The system will completely stop allowing the downloading or acquisition of new images due to incompatible software application versions.
- Action taken
- 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.
- Root cause
- Software Design Change
- Status
- Terminated
- Product code
- NFJ
- Quantity affected
- 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.
- Date initiated
- 2016-04-04
- Date posted
- 2017-03-13
- Date terminated
- 2020-06-22
- Location
- Hartland, WI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OIS SYMPHONY IMAGE MANAGMENT SYSTEM (K110006) | Ophthalmic Imaging Systems | 2011-05-18 |
| DFC-1024 & DFC-512 DIGITAL IMAGING SYSTEM (K913929) | Ophthalmic Imaging Systems | 1991-11-27 |