eFilm Workstation 4 — Class II medical device recall Z-0068-2015
Terminated recall by Merge Healthcare, Inc., reported 2014-10-22, distributed nationwide. There is an issue related to eFilm Workstation versions 4.0 and 4.0.1 when having multiple studies open and ut
| Recall number | Z-0068-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merge Healthcare, Inc., Hartland, WI, United States |
| Recall initiated | 2014-08-28 |
| Classified | 2014-10-14 |
| Reported by FDA | 2014-10-22 |
| Terminated | 2017-06-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, CA, CL, DE, FR, HU, IS, IT, LT, MX, NZ, RO, RU, SE, ZA |
| Quantity | 2,630 |
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 networks at distributed locations. Tasks that users may perform when viewing images include, but are not limited to: adjustment of window width and level; image stacking; annotation and measurement of regions of interest; and inversion, rotation, and flips of images. In addition, eFilm Workstation can be integrated with an institution s existing HIS or RIS for a fully integrated electronic patient record.
Reason for recall
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.