Merge Eye Care PACS Viewer 5.2 Merge Eye Care PACS is a software solution for the display, management, archive, interfac
FDA device recall Z-2754-2017 · posted 2017-07-10 · Terminated
Recall details
- Recalling firm
- Merge Healthcare, Inc.
- Reason for recall
- When the user has not set up any user preference on the sorting order to render the study images (OS/OD/etc.) and reports, the ECP may get an incorrect study index. If the user attempts to delete an image, ECP may then read that image as OS when it is, in fact, OD.
- Action taken
- The firm initiated the recall by certified letter the week of 06/26/2017. The notice provided the work-around and requested a response.
- Root cause
- Software design
- Status
- Terminated
- Product code
- NFJ
- Quantity affected
- 18 units
- Distribution
- FL, IL, CO, MI, CA, NY, ND, OH, CT
- Date initiated
- 2017-06-13
- Date posted
- 2017-07-10
- Date terminated
- 2020-09-17
- 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 |