Class II — Merge Healthcare, Inc.
| Recalling firm | Merge Healthcare |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | There is an issue related to eFilm Workstation versions 4.0 and 4.0.1 when having multiple studies open and utilizing the thumbnail panel to select multiple series from multiple studies may lead to the selection of an incorrect study. |
| Product | eFilm Workstation 4.0 and 4.0.1. eFilm Workstation is one of the components of a PACS (Picture Archiving and Communications System). Product Usage: eFilm Workstation is a software application that is used for viewing medical images. eFilm Workstation receives digital images and data from various sources (including but not limited to CT,MR, US, RF units, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways or imaging sources). Images are stored, communicated, processed and displayed on the local disc of a workstation and/or across computer netwo… |
| Quantity | 2,630 |
| Distribution | Worldwide Distribution - US Nationwide and the countries of : Argentina, Australia, Canada, Chile, France, Germany, Hungary, Iceland, Italy, Lithuania, Mexico, New Zealand, Romania, Russia, South Africa, Sweden, and Yemen. |
| Initiated | 2014-08-28 |
| Classified | 2014-10-14 |
| Terminated | 2017-06-01 |
| Recall number | Z-0068-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Merge Healthcare, Inc. (Z-0068-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/69295/
Alerts for Merge Healthcare
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.